Trial Outcomes & Findings for PMCF Study on PEEK Suture Anchors for Shoulder Indications (NCT NCT03826667)
NCT ID: NCT03826667
Last Updated: 2022-04-12
Results Overview
Clinical success was defined as shoulder repairs without signs of device failure and/or re-intervention as assessed by the surgeon. Specifically, clinical success was considered "Yes" based on the following 3 main criteria: * no inflammatory or allergic response * no device-related adverse event (AE) * no device deficiencies (DDs) leading to revision surgery (re intervention) on the index shoulder
Recruitment status
COMPLETED
Target enrollment
464 participants
Primary outcome timeframe
6 months
Results posted on
2022-04-12
Participant Flow
It was intended to enroll participants for 8 PEEK suture anchor devices; however, no participants were enrolled for the BIORAPTOR™ Knotless Suture Anchors, resulting in 7 suture anchor groups being analyzed. A total of 464 participants were enrolled in the study and 467 joints were observed. Multiple devices were implanted in 124 participants.
Unit of analysis: joints
Participant milestones
| Measure |
Polyetheretherketone (PEEK) Shoulder Suture Anchors
Participants who have received PEEK Suture Anchors in the shoulder which included:
HEALICOIL™ PK Preloaded Suture Anchors, BIORAPTOR™ 2.3 PK Suture Anchors/BIORAPTOR™ Curved 2.3 PK Suture Anchors, MULTIFIX™ S Ultra Knotless Fixation System, FOOTPRINT™ Ultra PK Suture Anchors, TWINFIX™ Ultra PK Suture Anchors/TWINFIX™ Ultra Preloaded and with Needles, SPEEDSCREW™ Knotless Fixation System, SpeedLock Knotless Fixation Device
|
|---|---|
|
Overall Study
STARTED
|
464 467
|
|
Overall Study
HEALICOIL™ PK Preloaded Suture Anchors
|
193 193
|
|
Overall Study
BIORAPTOR™ 2.3 PK Suture Anchors/BIORAPTOR™ Curved 2.3 PK Suture Anchors
|
41 41
|
|
Overall Study
MULTIFIX™ S Ultra Knotless Fixation System
|
78 78
|
|
Overall Study
FOOTPRINT™ Ultra PK Suture Anchors
|
136 138
|
|
Overall Study
TWINFIX™ Ultra PK Suture Anchors/TWINFIX™ Ultra Preloaded and With Needles
|
57 57
|
|
Overall Study
SPEEDSCREW™ Knotless Fixation System
|
59 59
|
|
Overall Study
SpeedLock Knotless Fixation Device
|
18 18
|
|
Overall Study
COMPLETED
|
443 446
|
|
Overall Study
NOT COMPLETED
|
21 21
|
Reasons for withdrawal
| Measure |
Polyetheretherketone (PEEK) Shoulder Suture Anchors
Participants who have received PEEK Suture Anchors in the shoulder which included:
HEALICOIL™ PK Preloaded Suture Anchors, BIORAPTOR™ 2.3 PK Suture Anchors/BIORAPTOR™ Curved 2.3 PK Suture Anchors, MULTIFIX™ S Ultra Knotless Fixation System, FOOTPRINT™ Ultra PK Suture Anchors, TWINFIX™ Ultra PK Suture Anchors/TWINFIX™ Ultra Preloaded and with Needles, SPEEDSCREW™ Knotless Fixation System, SpeedLock Knotless Fixation Device
|
|---|---|
|
Overall Study
Protocol deviation
|
21
|
Baseline Characteristics
Data was not available for all participants due to the retrospective nature of the study.
Baseline characteristics by cohort
| Measure |
Polyetheretherketone (PEEK) Shoulder Suture Anchors
n=467 joints
Participants who have received PEEK Suture Anchors in the shoulder which included:
HEALICOIL™ PK Preloaded Suture Anchors, BIORAPTOR™ 2.3 PK Suture Anchors/BIORAPTOR™ Curved 2.3 PK Suture Anchors, MULTIFIX™ S Ultra Knotless Fixation System, FOOTPRINT™ Ultra PK Suture Anchors, TWINFIX™ Ultra PK Suture Anchors/TWINFIX™ Ultra Preloaded and with Needles, SPEEDSCREW™ Knotless Fixation System, SpeedLock Knotless Fixation Device
|
|---|---|
|
Age, Continuous
|
54.00 years
STANDARD_DEVIATION 14.10 • n=467 joints
|
|
Sex: Female, Male
Female
|
190 joints
n=467 joints
|
|
Sex: Female, Male
Male
|
277 joints
n=467 joints
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
30 joints
n=467 joints
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
367 joints
n=467 joints
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
70 joints
n=467 joints
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native · No
|
462 joints
n=467 joints
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native · Yes
|
5 joints
n=467 joints
|
|
Race/Ethnicity, Customized
Asian · No
|
464 joints
n=467 joints
|
|
Race/Ethnicity, Customized
Asian · Yes
|
3 joints
n=467 joints
|
|
Race/Ethnicity, Customized
Black or African American · No
|
444 joints
n=467 joints
|
|
Race/Ethnicity, Customized
Black or African American · Yes
|
23 joints
n=467 joints
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander · No
|
465 joints
n=467 joints
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander · Yes
|
2 joints
n=467 joints
|
|
Race/Ethnicity, Customized
White · No
|
94 joints
n=467 joints
|
|
Race/Ethnicity, Customized
White · Yes
|
373 joints
n=467 joints
|
|
Race/Ethnicity, Customized
Other · No
|
403 joints
n=467 joints
|
|
Race/Ethnicity, Customized
Other · Yes
|
64 joints
n=467 joints
|
|
Region of Enrollment
United States
|
467 joints
n=467 joints
|
|
Location of Device Implantation
Left Shoulder
|
194 joints
n=467 joints
|
|
Location of Device Implantation
Right Shoulder
|
271 joints
n=467 joints
|
|
Location of Device Implantation
Bilaterally
|
2 joints
n=467 joints
|
|
Duration of Surgery
|
99.2 minutes
STANDARD_DEVIATION 50.7 • n=113 Participants • Data was not available for all participants due to the retrospective nature of the study.
|
|
Duration of time from injury to surgery
|
405.7 days
STANDARD_DEVIATION 929.2 • n=235 Participants • Data not available for all participants due to the retrospective nature of the study.
|
|
Any Medical History
Yes
|
392 joints
n=467 joints
|
|
Any Medical History
No
|
75 joints
n=467 joints
|
|
Number of Participant Joints Treated by Indication
Bankart lesion repair
|
12 joints
n=467 joints
|
|
Number of Participant Joints Treated by Indication
SLAP lesion repair
|
2 joints
n=467 joints
|
|
Number of Participant Joints Treated by Indication
Capsular shift
|
5 joints
n=467 joints
|
|
Number of Participant Joints Treated by Indication
Rotator cuff repair
|
413 joints
n=467 joints
|
|
Number of Participant Joints Treated by Indication
Biceps tenodesis
|
33 joints
n=467 joints
|
|
Number of Participant Joints Treated by Indication
Other
|
2 joints
n=467 joints
|
|
Disposition of Suture Anchors
HEALICOIL™ PK Preloaded Suture Anchors
|
193 Participants
n=464 Participants • Information provided based on the unique device implanted. Out of 464 overall participants, 124 were implanted with multiple Suture Anchors (devices).
|
|
Disposition of Suture Anchors
BIORAPTOR™ 2.3 PK Suture Anchor / BIORAPTOR™ Curved 2.3 PK Suture Anchor
|
41 Participants
n=464 Participants • Information provided based on the unique device implanted. Out of 464 overall participants, 124 were implanted with multiple Suture Anchors (devices).
|
|
Disposition of Suture Anchors
MULTIFIX™ S Ultra Knotless Fixation System
|
78 Participants
n=464 Participants • Information provided based on the unique device implanted. Out of 464 overall participants, 124 were implanted with multiple Suture Anchors (devices).
|
|
Disposition of Suture Anchors
FOOTPRINT™ Ultra PK Suture Anchor
|
136 Participants
n=464 Participants • Information provided based on the unique device implanted. Out of 464 overall participants, 124 were implanted with multiple Suture Anchors (devices).
|
|
Disposition of Suture Anchors
TWINFIX™ Ultra PK Suture Anchor
|
57 Participants
n=464 Participants • Information provided based on the unique device implanted. Out of 464 overall participants, 124 were implanted with multiple Suture Anchors (devices).
|
|
Disposition of Suture Anchors
SPEEDSCREW™ Knotless Fixation System
|
59 Participants
n=464 Participants • Information provided based on the unique device implanted. Out of 464 overall participants, 124 were implanted with multiple Suture Anchors (devices).
|
|
Disposition of Suture Anchors
SpeedLock Knotless Fixation Device
|
18 Participants
n=464 Participants • Information provided based on the unique device implanted. Out of 464 overall participants, 124 were implanted with multiple Suture Anchors (devices).
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Number of participants analyzed at the specified time frame for each row indicates participant provided retrospective data for the PEEK Suture Anchor identified. Some participants were implanted with multiple Suture Anchors (devices).Data was analyzed independently based on specific device implanted (i.e., participants with multiple devices were analyzed individually by unique suture anchor). Overall number of participants analyzed indicates combined total of distinct participants assessed.
Clinical success was defined as shoulder repairs without signs of device failure and/or re-intervention as assessed by the surgeon. Specifically, clinical success was considered "Yes" based on the following 3 main criteria: * no inflammatory or allergic response * no device-related adverse event (AE) * no device deficiencies (DDs) leading to revision surgery (re intervention) on the index shoulder
Outcome measures
| Measure |
Polyetheretherketone (PEEK) Shoulder Suture Anchors
n=458 Participants
Participants who have received PEEK Suture Anchors in the shoulder which included:
HEALICOIL™ PK Preloaded Suture Anchors, BIORAPTOR™ 2.3 PK Suture Anchors/BIORAPTOR™ Curved 2.3 PK Suture Anchors, MULTIFIX™ S Ultra Knotless Fixation System, FOOTPRINT™ Ultra PK Suture Anchors, TWINFIX™ Ultra PK Suture Anchors/TWINFIX™ Ultra Preloaded and with Needles, SPEEDSCREW™ Knotless Fixation System, SpeedLock Knotless Fixation Device
|
|---|---|
|
Number of Participants With Clinical Success of the Study Devices in the Shoulder Over a Time Period of 6 Months After Intervention
HEALICOIL™ PK Preloaded Suture Anchors · Yes
|
185 Participants
|
|
Number of Participants With Clinical Success of the Study Devices in the Shoulder Over a Time Period of 6 Months After Intervention
HEALICOIL™ PK Preloaded Suture Anchors · No
|
6 Participants
|
|
Number of Participants With Clinical Success of the Study Devices in the Shoulder Over a Time Period of 6 Months After Intervention
BIORAPTOR™ 2.3 PK Suture Anchor / BIORAPTOR™ Curved 2.3 PK Suture Anchor · Yes
|
38 Participants
|
|
Number of Participants With Clinical Success of the Study Devices in the Shoulder Over a Time Period of 6 Months After Intervention
BIORAPTOR™ 2.3 PK Suture Anchor / BIORAPTOR™ Curved 2.3 PK Suture Anchor · No
|
3 Participants
|
|
Number of Participants With Clinical Success of the Study Devices in the Shoulder Over a Time Period of 6 Months After Intervention
MULTIFIX™ S Ultra Knotless Fixation System · Yes
|
71 Participants
|
|
Number of Participants With Clinical Success of the Study Devices in the Shoulder Over a Time Period of 6 Months After Intervention
MULTIFIX™ S Ultra Knotless Fixation System · No
|
6 Participants
|
|
Number of Participants With Clinical Success of the Study Devices in the Shoulder Over a Time Period of 6 Months After Intervention
FOOTPRINT™ Ultra PK Suture Anchor · Yes
|
128 Participants
|
|
Number of Participants With Clinical Success of the Study Devices in the Shoulder Over a Time Period of 6 Months After Intervention
FOOTPRINT™ Ultra PK Suture Anchor · No
|
3 Participants
|
|
Number of Participants With Clinical Success of the Study Devices in the Shoulder Over a Time Period of 6 Months After Intervention
TWINFIX™ Ultra PK Suture Anchor · Yes
|
57 Participants
|
|
Number of Participants With Clinical Success of the Study Devices in the Shoulder Over a Time Period of 6 Months After Intervention
TWINFIX™ Ultra PK Suture Anchor · No
|
0 Participants
|
|
Number of Participants With Clinical Success of the Study Devices in the Shoulder Over a Time Period of 6 Months After Intervention
SPEEDSCREW™ Knotless Fixation System · Yes
|
58 Participants
|
|
Number of Participants With Clinical Success of the Study Devices in the Shoulder Over a Time Period of 6 Months After Intervention
SPEEDSCREW™ Knotless Fixation System · No
|
1 Participants
|
|
Number of Participants With Clinical Success of the Study Devices in the Shoulder Over a Time Period of 6 Months After Intervention
SpeedLock Knotless Fixation Device · Yes
|
18 Participants
|
|
Number of Participants With Clinical Success of the Study Devices in the Shoulder Over a Time Period of 6 Months After Intervention
SpeedLock Knotless Fixation Device · No
|
0 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Number of participants analyzed at the specified time frame for each row indicates participant provided retrospective data for the PEEK Suture Anchor identified. Some participants were implanted with multiple Suture Anchors (devices).Data was analyzed independently based on specific device implanted (i.e., participants with multiple devices were analyzed individually by unique suture anchor). Overall number of participants analyzed indicates combined total of distinct participants assessed.
Clinical success was defined as shoulder repairs without signs of device failure and/or re-intervention as assessed by the surgeon. Specifically, clinical success was considered "Yes" based on the following 3 main criteria: * no inflammatory or allergic response * no device-related adverse event (AE) * no device deficiencies (DDs) leading to revision surgery (re intervention) on the index shoulder
Outcome measures
| Measure |
Polyetheretherketone (PEEK) Shoulder Suture Anchors
n=85 Participants
Participants who have received PEEK Suture Anchors in the shoulder which included:
HEALICOIL™ PK Preloaded Suture Anchors, BIORAPTOR™ 2.3 PK Suture Anchors/BIORAPTOR™ Curved 2.3 PK Suture Anchors, MULTIFIX™ S Ultra Knotless Fixation System, FOOTPRINT™ Ultra PK Suture Anchors, TWINFIX™ Ultra PK Suture Anchors/TWINFIX™ Ultra Preloaded and with Needles, SPEEDSCREW™ Knotless Fixation System, SpeedLock Knotless Fixation Device
|
|---|---|
|
Number of Participants With Clinical Success of the Study Devices in the Shoulder Over a Time Period of 12 Months After Intervention
HEALICOIL™ PK Preloaded Suture Anchors · Yes
|
50 Participants
|
|
Number of Participants With Clinical Success of the Study Devices in the Shoulder Over a Time Period of 12 Months After Intervention
HEALICOIL™ PK Preloaded Suture Anchors · No
|
1 Participants
|
|
Number of Participants With Clinical Success of the Study Devices in the Shoulder Over a Time Period of 12 Months After Intervention
BIORAPTOR™ 2.3 PK Suture Anchor / BIORAPTOR™ Curved 2.3 PK Suture Anchor · Yes
|
5 Participants
|
|
Number of Participants With Clinical Success of the Study Devices in the Shoulder Over a Time Period of 12 Months After Intervention
BIORAPTOR™ 2.3 PK Suture Anchor / BIORAPTOR™ Curved 2.3 PK Suture Anchor · No
|
0 Participants
|
|
Number of Participants With Clinical Success of the Study Devices in the Shoulder Over a Time Period of 12 Months After Intervention
MULTIFIX™ S Ultra Knotless Fixation System · Yes
|
17 Participants
|
|
Number of Participants With Clinical Success of the Study Devices in the Shoulder Over a Time Period of 12 Months After Intervention
MULTIFIX™ S Ultra Knotless Fixation System · No
|
1 Participants
|
|
Number of Participants With Clinical Success of the Study Devices in the Shoulder Over a Time Period of 12 Months After Intervention
FOOTPRINT™ Ultra PK Suture Anchor · Yes
|
16 Participants
|
|
Number of Participants With Clinical Success of the Study Devices in the Shoulder Over a Time Period of 12 Months After Intervention
FOOTPRINT™ Ultra PK Suture Anchor · No
|
2 Participants
|
|
Number of Participants With Clinical Success of the Study Devices in the Shoulder Over a Time Period of 12 Months After Intervention
TWINFIX™ Ultra PK Suture Anchor · Yes
|
6 Participants
|
|
Number of Participants With Clinical Success of the Study Devices in the Shoulder Over a Time Period of 12 Months After Intervention
TWINFIX™ Ultra PK Suture Anchor · No
|
0 Participants
|
|
Number of Participants With Clinical Success of the Study Devices in the Shoulder Over a Time Period of 12 Months After Intervention
SPEEDSCREW™ Knotless Fixation System · Yes
|
4 Participants
|
|
Number of Participants With Clinical Success of the Study Devices in the Shoulder Over a Time Period of 12 Months After Intervention
SPEEDSCREW™ Knotless Fixation System · No
|
1 Participants
|
|
Number of Participants With Clinical Success of the Study Devices in the Shoulder Over a Time Period of 12 Months After Intervention
SpeedLock Knotless Fixation Device · Yes
|
2 Participants
|
|
Number of Participants With Clinical Success of the Study Devices in the Shoulder Over a Time Period of 12 Months After Intervention
SpeedLock Knotless Fixation Device · No
|
0 Participants
|
SECONDARY outcome
Timeframe: 6 and 12 monthsPopulation: Number of participants analyzed at the specified time frame for each row indicates participant provided retrospective data for the PEEK Suture Anchor identified. Some participants were implanted with multiple Suture Anchors (devices).Data was analyzed independently based on specific device implanted (i.e., participants with multiple devices were analyzed individually by unique suture anchor). Overall number of participants analyzed indicates combined total of distinct participants assessed.
The VAS is a continuous scale comprised of a horizontal line 100 millimeters (mm) in length, anchored by 2 verbal descriptors, one for each symptom extreme. The VAS pain score is presented on a scale ranging from 0 to 10. A score of 0 represents no pain (0 mm) and a score of 10 indicates extreme/unbearable pain (100 mm). The VAS rating was recorded retrospectively, per standard of care at 6 and 12 months post-surgery.
Outcome measures
| Measure |
Polyetheretherketone (PEEK) Shoulder Suture Anchors
n=100 Participants
Participants who have received PEEK Suture Anchors in the shoulder which included:
HEALICOIL™ PK Preloaded Suture Anchors, BIORAPTOR™ 2.3 PK Suture Anchors/BIORAPTOR™ Curved 2.3 PK Suture Anchors, MULTIFIX™ S Ultra Knotless Fixation System, FOOTPRINT™ Ultra PK Suture Anchors, TWINFIX™ Ultra PK Suture Anchors/TWINFIX™ Ultra Preloaded and with Needles, SPEEDSCREW™ Knotless Fixation System, SpeedLock Knotless Fixation Device
|
|---|---|
|
Visual Analog Scale (VAS) - Pain
SpeedLock Knotless Fixation Device: 6 months
|
0 score on a scale
Standard Deviation 0
|
|
Visual Analog Scale (VAS) - Pain
HEALICOIL™ PK Preloaded Suture Anchors: 6 months
|
1.8 score on a scale
Standard Deviation 2.1
|
|
Visual Analog Scale (VAS) - Pain
HEALICOIL™ PK Preloaded Suture Anchors: 12 months
|
2.4 score on a scale
Standard Deviation 1.8
|
|
Visual Analog Scale (VAS) - Pain
BIORAPTOR™ 2.3 PK Suture Anchor / BIORAPTOR™ Curved 2.3 PK Suture Anchor: 6 months
|
2.5 score on a scale
Standard Deviation 2.8
|
|
Visual Analog Scale (VAS) - Pain
BIORAPTOR™ 2.3 PK Suture Anchor / BIORAPTOR™ Curved 2.3 PK Suture Anchor: 12 months
|
4.5 score on a scale
Standard Deviation 0.7
|
|
Visual Analog Scale (VAS) - Pain
MULTIFIX™ S Ultra Knotless Fixation System: 6 months
|
2.2 score on a scale
Standard Deviation 2.1
|
|
Visual Analog Scale (VAS) - Pain
MULTIFIX™ S Ultra Knotless Fixation System: 12 months
|
2.3 score on a scale
Standard Deviation 1.9
|
|
Visual Analog Scale (VAS) - Pain
FOOTPRINT™ Ultra PK Suture Anchor: 6 months
|
2.3 score on a scale
Standard Deviation 2.1
|
|
Visual Analog Scale (VAS) - Pain
SPEEDSCREW™ Knotless Fixation System: 6 months
|
1.4 score on a scale
Standard Deviation 3.1
|
SECONDARY outcome
Timeframe: 6 and 12 monthsPopulation: Number of participants analyzed at the specified time frame for each row indicates participant provided retrospective data for the PEEK Suture Anchor identified. Some participants were implanted with multiple Suture Anchors (devices).Data was analyzed independently based on specific device implanted (i.e., participants with multiple devices were analyzed individually by unique suture anchor). Overall number of participants analyzed indicates combined total of distinct participants assessed.
Range of motion defined as the participant having a full functional arc "Yes" or "No" at 6 month and 12 month post-operative visits.
Outcome measures
| Measure |
Polyetheretherketone (PEEK) Shoulder Suture Anchors
n=348 Participants
Participants who have received PEEK Suture Anchors in the shoulder which included:
HEALICOIL™ PK Preloaded Suture Anchors, BIORAPTOR™ 2.3 PK Suture Anchors/BIORAPTOR™ Curved 2.3 PK Suture Anchors, MULTIFIX™ S Ultra Knotless Fixation System, FOOTPRINT™ Ultra PK Suture Anchors, TWINFIX™ Ultra PK Suture Anchors/TWINFIX™ Ultra Preloaded and with Needles, SPEEDSCREW™ Knotless Fixation System, SpeedLock Knotless Fixation Device
|
|---|---|
|
Count of Participants With Range of Motion (ROM) Full Functional Arc
HEALICOIL™ PK Preloaded Suture Anchors: 6 months · Has full functional arc: Yes
|
111 Participants
|
|
Count of Participants With Range of Motion (ROM) Full Functional Arc
HEALICOIL™ PK Preloaded Suture Anchors: 6 months · Has full functional arc: No
|
48 Participants
|
|
Count of Participants With Range of Motion (ROM) Full Functional Arc
HEALICOIL™ PK Preloaded Suture Anchors: 6 months · Has full functional arc: Unknown
|
4 Participants
|
|
Count of Participants With Range of Motion (ROM) Full Functional Arc
HEALICOIL™ PK Preloaded Suture Anchors: 12 months · Has full functional arc: Yes
|
37 Participants
|
|
Count of Participants With Range of Motion (ROM) Full Functional Arc
HEALICOIL™ PK Preloaded Suture Anchors: 12 months · Has full functional arc: No
|
10 Participants
|
|
Count of Participants With Range of Motion (ROM) Full Functional Arc
HEALICOIL™ PK Preloaded Suture Anchors: 12 months · Has full functional arc: Unknown
|
2 Participants
|
|
Count of Participants With Range of Motion (ROM) Full Functional Arc
BIORAPTOR™ 2.3 PK Suture Anchor / BIORAPTOR™ Curved 2.3 PK Suture Anchor: 6 months · Has full functional arc: Yes
|
29 Participants
|
|
Count of Participants With Range of Motion (ROM) Full Functional Arc
BIORAPTOR™ 2.3 PK Suture Anchor / BIORAPTOR™ Curved 2.3 PK Suture Anchor: 6 months · Has full functional arc: No
|
3 Participants
|
|
Count of Participants With Range of Motion (ROM) Full Functional Arc
BIORAPTOR™ 2.3 PK Suture Anchor / BIORAPTOR™ Curved 2.3 PK Suture Anchor: 6 months · Has full functional arc: Unknown
|
1 Participants
|
|
Count of Participants With Range of Motion (ROM) Full Functional Arc
BIORAPTOR™ 2.3 PK Suture Anchor / BIORAPTOR™ Curved 2.3 PK Suture Anchor: 12 months · Has full functional arc: Yes
|
1 Participants
|
|
Count of Participants With Range of Motion (ROM) Full Functional Arc
BIORAPTOR™ 2.3 PK Suture Anchor / BIORAPTOR™ Curved 2.3 PK Suture Anchor: 12 months · Has full functional arc: No
|
1 Participants
|
|
Count of Participants With Range of Motion (ROM) Full Functional Arc
BIORAPTOR™ 2.3 PK Suture Anchor / BIORAPTOR™ Curved 2.3 PK Suture Anchor: 12 months · Has full functional arc: Unknown
|
0 Participants
|
|
Count of Participants With Range of Motion (ROM) Full Functional Arc
MULTIFIX™ S Ultra Knotless Fixation System: 6 months · Has full functional arc: Yes
|
35 Participants
|
|
Count of Participants With Range of Motion (ROM) Full Functional Arc
MULTIFIX™ S Ultra Knotless Fixation System: 6 months · Has full functional arc: No
|
12 Participants
|
|
Count of Participants With Range of Motion (ROM) Full Functional Arc
MULTIFIX™ S Ultra Knotless Fixation System: 6 months · Has full functional arc: Unknown
|
4 Participants
|
|
Count of Participants With Range of Motion (ROM) Full Functional Arc
MULTIFIX™ S Ultra Knotless Fixation System: 12 months · Has full functional arc: Yes
|
9 Participants
|
|
Count of Participants With Range of Motion (ROM) Full Functional Arc
MULTIFIX™ S Ultra Knotless Fixation System: 12 months · Has full functional arc: No
|
7 Participants
|
|
Count of Participants With Range of Motion (ROM) Full Functional Arc
MULTIFIX™ S Ultra Knotless Fixation System: 12 months · Has full functional arc: Unknown
|
0 Participants
|
|
Count of Participants With Range of Motion (ROM) Full Functional Arc
FOOTPRINT™ Ultra PK Suture Anchor: 6 months · Has full functional arc: Yes
|
90 Participants
|
|
Count of Participants With Range of Motion (ROM) Full Functional Arc
FOOTPRINT™ Ultra PK Suture Anchor: 6 months · Has full functional arc: No
|
14 Participants
|
|
Count of Participants With Range of Motion (ROM) Full Functional Arc
FOOTPRINT™ Ultra PK Suture Anchor: 6 months · Has full functional arc: Unknown
|
1 Participants
|
|
Count of Participants With Range of Motion (ROM) Full Functional Arc
FOOTPRINT™ Ultra PK Suture Anchor: 12 months · Has full functional arc: Yes
|
17 Participants
|
|
Count of Participants With Range of Motion (ROM) Full Functional Arc
FOOTPRINT™ Ultra PK Suture Anchor: 12 months · Has full functional arc: No
|
2 Participants
|
|
Count of Participants With Range of Motion (ROM) Full Functional Arc
FOOTPRINT™ Ultra PK Suture Anchor: 12 months · Has full functional arc: Unknown
|
0 Participants
|
|
Count of Participants With Range of Motion (ROM) Full Functional Arc
SPEEDSCREW™ Knotless Fixation System: 6 months · Has full functional arc: Yes
|
46 Participants
|
|
Count of Participants With Range of Motion (ROM) Full Functional Arc
SPEEDSCREW™ Knotless Fixation System: 6 months · Has full functional arc: No
|
5 Participants
|
|
Count of Participants With Range of Motion (ROM) Full Functional Arc
SPEEDSCREW™ Knotless Fixation System: 6 months · Has full functional arc: Unknown
|
3 Participants
|
|
Count of Participants With Range of Motion (ROM) Full Functional Arc
SPEEDSCREW™ Knotless Fixation System: 12 months · Has full functional arc: Yes
|
4 Participants
|
|
Count of Participants With Range of Motion (ROM) Full Functional Arc
SPEEDSCREW™ Knotless Fixation System: 12 months · Has full functional arc: No
|
1 Participants
|
|
Count of Participants With Range of Motion (ROM) Full Functional Arc
SPEEDSCREW™ Knotless Fixation System: 12 months · Has full functional arc: Unknown
|
0 Participants
|
|
Count of Participants With Range of Motion (ROM) Full Functional Arc
SpeedLock Knotless Fixation Device: 6 months · Has full functional arc: Yes
|
18 Participants
|
|
Count of Participants With Range of Motion (ROM) Full Functional Arc
SpeedLock Knotless Fixation Device: 6 months · Has full functional arc: No
|
0 Participants
|
|
Count of Participants With Range of Motion (ROM) Full Functional Arc
SpeedLock Knotless Fixation Device: 6 months · Has full functional arc: Unknown
|
0 Participants
|
|
Count of Participants With Range of Motion (ROM) Full Functional Arc
SpeedLock Knotless Fixation Device: 12 months · Has full functional arc: Yes
|
2 Participants
|
|
Count of Participants With Range of Motion (ROM) Full Functional Arc
SpeedLock Knotless Fixation Device: 12 months · Has full functional arc: No
|
0 Participants
|
|
Count of Participants With Range of Motion (ROM) Full Functional Arc
SpeedLock Knotless Fixation Device: 12 months · Has full functional arc: Unknown
|
0 Participants
|
SECONDARY outcome
Timeframe: 6 and 12 monthsPopulation: Number of participants analyzed at the specified time frame for each row indicates participant provided retrospective data for the PEEK Suture Anchor identified. Some participants were implanted with multiple Suture Anchors (devices).Data was analyzed independently based on specific device implanted (i.e., participants with multiple devices were analyzed individually by unique suture anchor). Overall number of participants analyzed indicates combined total of distinct participants assessed.
Forward flexion angle, internal rotation angle, and external rotation angle captured in degrees based on physician's Standard of Care.
Outcome measures
| Measure |
Polyetheretherketone (PEEK) Shoulder Suture Anchors
n=70 Participants
Participants who have received PEEK Suture Anchors in the shoulder which included:
HEALICOIL™ PK Preloaded Suture Anchors, BIORAPTOR™ 2.3 PK Suture Anchors/BIORAPTOR™ Curved 2.3 PK Suture Anchors, MULTIFIX™ S Ultra Knotless Fixation System, FOOTPRINT™ Ultra PK Suture Anchors, TWINFIX™ Ultra PK Suture Anchors/TWINFIX™ Ultra Preloaded and with Needles, SPEEDSCREW™ Knotless Fixation System, SpeedLock Knotless Fixation Device
|
|---|---|
|
Range of Motion (ROM)
HEALICOIL™ PK Preloaded Suture Anchors: Forward Flexion Angle (6 months)
|
157 degrees
Standard Deviation 20.2
|
|
Range of Motion (ROM)
HEALICOIL™ PK Preloaded Suture Anchors: Internal Rotation Angle (6 months)
|
25.7 degrees
Standard Deviation 40.6
|
|
Range of Motion (ROM)
HEALICOIL™ PK Preloaded Suture Anchors: External Rotation (6 months)
|
49.3 degrees
Standard Deviation 20.5
|
|
Range of Motion (ROM)
HEALICOIL™ PK Preloaded Suture Anchors Forward Flexion Angle (12 months)
|
141.1 degrees
Standard Deviation 39.8
|
|
Range of Motion (ROM)
HEALICOIL™ PK Preloaded Suture Anchors Internal Rotation Angle (12 months)
|
75 degrees
Standard Deviation 21.2
|
|
Range of Motion (ROM)
HEALICOIL™ PK Preloaded Suture Anchors External Rotation (12 months)
|
59.4 degrees
Standard Deviation 25.7
|
|
Range of Motion (ROM)
BIORAPTOR™ 2.3 PK /BIORAPTOR™ Curved 2.3 PK Suture Anchor: Forward Flexion Angle (6 months)
|
89 degrees
Standard Deviation 100.4
|
|
Range of Motion (ROM)
BIORAPTOR™ 2.3 PK /BIORAPTOR™ Curved 2.3 PK Suture Anchor: Internal Rotation Angle (6 months)
|
60 degrees
Standard Deviation 15
|
|
Range of Motion (ROM)
BIORAPTOR™ 2.3 PK /BIORAPTOR™ Curved 2.3 PK Suture Anchor: External Rotation (6 months)
|
100 degrees
Standard Deviation 30
|
|
Range of Motion (ROM)
MULTIFIX™ S Ultra Knotless Fixation System: Forward Flexion Angle (6 months)
|
122.5 degrees
Standard Deviation 39.4
|
|
Range of Motion (ROM)
MULTIFIX™ S Ultra Knotless Fixation System: Internal Rotation Angle (6 months)
|
90 degrees
Standard Deviation NA
Standard deviation not calculated whenever there was only 1 participant's data available
|
|
Range of Motion (ROM)
MULTIFIX™ S Ultra Knotless Fixation System: External Rotation (6 months)
|
59.8 degrees
Standard Deviation 25.3
|
|
Range of Motion (ROM)
MULTIFIX™ S Ultra Knotless Fixation System: Forward Flexion Angle (12 months)
|
141.7 degrees
Standard Deviation 38.2
|
|
Range of Motion (ROM)
MULTIFIX™ S Ultra Knotless Fixation System: Internal Rotation Angle (12 months)
|
75 degrees
Standard Deviation 21.2
|
|
Range of Motion (ROM)
MULTIFIX™ S Ultra Knotless Fixation System: External Rotation (12 months)
|
76 degrees
Standard Deviation 21.9
|
|
Range of Motion (ROM)
FOOTPRINT™ Ultra PK Suture Anchor: Forward Flexion Angle (6 months)
|
137.5 degrees
Standard Deviation 35.9
|
|
Range of Motion (ROM)
FOOTPRINT™ Ultra PK Suture Anchor: Internal Rotation Angle (6 months)
|
86.3 degrees
Standard Deviation 30.9
|
|
Range of Motion (ROM)
FOOTPRINT™ Ultra PK Suture Anchor: External Rotation (6 months)
|
50 degrees
Standard Deviation 22.7
|
|
Range of Motion (ROM)
FOOTPRINT™ Ultra PK Suture Anchor: Forward Flexion Angle (12 months)
|
140 degrees
Standard Deviation 28.3
|
|
Range of Motion (ROM)
FOOTPRINT™ Ultra PK Suture Anchor: External Rotation (12 months)
|
60 degrees
Standard Deviation 0
|
|
Range of Motion (ROM)
SPEEDSCREW™ Knotless Fixation System: Forward Flexion Angle (6 months)
|
122 degrees
Standard Deviation 46.0
|
|
Range of Motion (ROM)
SPEEDSCREW™ Knotless Fixation System: External Rotation (6 months)
|
35 degrees
Standard Deviation 10
|
|
Range of Motion (ROM)
SPEEDSCREW™ Knotless Fixation System: Forward Flexion Angle (12 months)
|
130 degrees
Standard Deviation NA
Standard deviation not calculated whenever there was only 1 participant's data available
|
|
Range of Motion (ROM)
SPEEDSCREW™ Knotless Fixation System: External Rotation (12 months)
|
50 degrees
Standard Deviation NA
Standard deviation not calculated whenever there was only 1 participant's data available
|
Adverse Events
HEALICOIL™ PK Preloaded Suture Anchors
Serious events: 15 serious events
Other events: 40 other events
Deaths: 0 deaths
BIORAPTOR™ 2.3 PK Suture Anchors/BIORAPTOR™ Curved 2.3 PK Suture Anchors
Serious events: 7 serious events
Other events: 27 other events
Deaths: 0 deaths
MULTIFIX™ S Ultra Knotless Fixation System
Serious events: 13 serious events
Other events: 38 other events
Deaths: 0 deaths
FOOTPRINT™ Ultra PK Suture Anchors
Serious events: 10 serious events
Other events: 24 other events
Deaths: 0 deaths
TWINFIX™ Ultra PK Suture Anchors/TWINFIX™ Ultra Preloaded and With Needles
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
SPEEDSCREW™ Knotless Fixation System
Serious events: 4 serious events
Other events: 4 other events
Deaths: 0 deaths
SpeedLock Knotless Fixation Device
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
HEALICOIL™ PK Preloaded Suture Anchors
n=193 participants at risk
Participants who have received PEEK Suture Anchor:
HEALICOIL™ PK Preloaded Suture Anchors
|
BIORAPTOR™ 2.3 PK Suture Anchors/BIORAPTOR™ Curved 2.3 PK Suture Anchors
n=41 participants at risk
Participants who have received PEEK Suture Anchor:
BIORAPTOR™ 2.3 PK Suture Anchors/BIORAPTOR™ Curved 2.3 PK Suture Anchors
|
MULTIFIX™ S Ultra Knotless Fixation System
n=78 participants at risk
Participants who have received PEEK Suture Anchor:
MULTIFIX™ S Ultra Knotless Fixation System
|
FOOTPRINT™ Ultra PK Suture Anchors
n=136 participants at risk
Participants who have received PEEK Suture Anchor:
FOOTPRINT™ Ultra PK Suture Anchors
|
TWINFIX™ Ultra PK Suture Anchors/TWINFIX™ Ultra Preloaded and With Needles
n=57 participants at risk
Participants who have received PEEK Suture Anchor:
TWINFIX™ Ultra PK Suture Anchors/TWINFIX™ Ultra Preloaded and with Needles
|
SPEEDSCREW™ Knotless Fixation System
n=59 participants at risk
Participants who have received PEEK Suture Anchor:
SPEEDSCREW™ Knotless Fixation System
|
SpeedLock Knotless Fixation Device
n=18 participants at risk
Participants who have received PEEK Suture Anchor:
SpeedLock Knotless Fixation Device
|
|---|---|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
ADHESIVE CAPSULITIS IN RIGHT SHOULDER
|
0.00%
0/193 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
1.3%
1/78 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
Blood and lymphatic system disorders
PULMONARY EMBOLUS
|
0.00%
0/193 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/78 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
1.7%
1/59 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
Injury, poisoning and procedural complications
RE-TEAR OF ROTATOR CUFF
|
1.0%
2/193 • Number of events 2 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/78 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.74%
1/136 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
1.8%
1/57 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
Nervous system disorders
RIGHT CARPAL TUNNEL WITH RELEASE
|
0.00%
0/193 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/78 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.74%
1/136 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
Injury, poisoning and procedural complications
LEFT SHOULDER RECURRENT ROTATOR CUFF TEAR
|
0.00%
0/193 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/78 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.74%
1/136 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
Injury, poisoning and procedural complications
R RECURRENT RTC TEAR AND IMPINGEMENT SYNDROME
|
0.00%
0/193 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/78 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.74%
1/136 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
Injury, poisoning and procedural complications
RECURRENT TEAR OF ROTATOR CUFF WITH NEW TEAR OF THE SUPRASPINATUS AND RECURRENT JOINT IMPINGEMENT
|
0.00%
0/193 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/78 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.74%
1/136 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
Musculoskeletal and connective tissue disorders
LEFT SHOULDER ADHESIVE CAPSULITIS
|
0.52%
1/193 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
1.3%
1/78 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
1.5%
2/136 • Number of events 2 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
General disorders
LEFT SHOULDER PAIN WITH RECURRENT RTC TEAR
|
0.00%
0/193 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/78 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.74%
1/136 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
Musculoskeletal and connective tissue disorders
DECREASED ROM RIGHT SHOULDER
|
0.00%
0/193 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/78 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.74%
1/136 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
General disorders
RIGHT SHOULDER INCREASE IN PAIN WITH POPPING AND GRINDING, RECURRENT RTC TEAR
|
0.52%
1/193 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
1.3%
1/78 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
Musculoskeletal and connective tissue disorders
CONTINUING WEAKNESS RIGHT SHOULDER AND DECREASED ROM
|
0.52%
1/193 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
1.3%
1/78 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
Musculoskeletal and connective tissue disorders
LEFT SHOULDER PAIN AND DECREASED ROM
|
0.52%
1/193 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
1.3%
1/78 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
Musculoskeletal and connective tissue disorders
RECURRENT RTC TEAR
|
1.0%
2/193 • Number of events 2 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
2.6%
2/78 • Number of events 2 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
General disorders
R SHOULDER INCREASED PAIN, WEAKNESS, LTD. ROM, R RECURRENT RTC TEAR
|
0.52%
1/193 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
1.3%
1/78 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
Musculoskeletal and connective tissue disorders
RIGHT SHOULDER ADHESIVE CAPSULITIS
|
0.52%
1/193 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
1.3%
1/78 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
Musculoskeletal and connective tissue disorders
R SHOULDER SUBACHROMIAL BURSITIS WITH SUPRASPINATOUS TENDINOSIS CAUSING DECREASED MOBILITY
|
0.52%
1/193 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
1.3%
1/78 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
General disorders
LEFT SHOULDER PAIN AND WEAKNESS RELATED TO RECURRENT RTC TEAR
|
0.52%
1/193 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
1.3%
1/78 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
Musculoskeletal and connective tissue disorders
RIGHT SHOULDER PAIN, TIGHTNESS AND SPASM WITH PERSISTENT WEAKNESS AND RECURRENT RTC TEAR
|
0.52%
1/193 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
1.3%
1/78 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
General disorders
FELT POP R SHOULDER, DECREASED ROM AND PAIN SINCE, RECURRENT RTC TEAR
|
0.52%
1/193 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
1.3%
1/78 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
General disorders
LEFT SHOULDER SWELLING AND PAIN AFTER PT STRETCH AND RECURRENT LEFT RTC TEAR
|
0.52%
1/193 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
1.3%
1/78 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
General disorders
R SHOULDER PAIN CREPITUS AND STIFFNESS WITH RECURRENT RTC TEAR,
|
0.52%
1/193 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
1.3%
1/78 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
General disorders
RIGHT SHOULDER PAIN AND WEAKNESS, RECURRENT R RTC TEAR,
|
0.52%
1/193 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
1.3%
1/78 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
General disorders
INCREASED PAIN, DECREASED ROM AND WEAKNESS, RECURRENT L RTC TEAR, INSOMNIA R/T PAIN
|
0.52%
1/193 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
1.3%
1/78 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
General disorders
WORSENING LEFT SHOULDER PAIN RADIATING DOWN LEFT ARM, RECURRENT LABRAL TEAR
|
0.00%
0/193 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
2.4%
1/41 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/78 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
Injury, poisoning and procedural complications
LEFT RTC TEAR, RTC CAPSULE SPRAIN
|
0.00%
0/193 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
2.4%
1/41 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/78 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
General disorders
LEFT SHOULDER PAIN WITH DECREASED ROM, STIFF AND SORE, ADHESIVE CAPSULITIS AND RTC TENDONITIS
|
0.00%
0/193 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
2.4%
1/41 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/78 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
General disorders
RIGHT SHOULDER PAIN, LTD ROM, RTC TEAR
|
0.00%
0/193 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
2.4%
1/41 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/78 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
Surgical and medical procedures
OCCASIONAL LEFT SHOULDER PAIN, STIFFNESS, ADHESIVE CAPSULITIS
|
0.00%
0/193 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
2.4%
1/41 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/78 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
Injury, poisoning and procedural complications
R SHOULDER TENDONITIS, PARTIAL RTC TEAR
|
0.00%
0/193 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
2.4%
1/41 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/78 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
Infections and infestations
R SHOULDER ANTERIOR WOUND INFECTION
|
0.00%
0/193 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
2.4%
1/41 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/78 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
General disorders
R SHOULDER PAIN, RECURRENT RTC TEAR
|
0.00%
0/193 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
2.4%
1/41 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/78 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
Injury, poisoning and procedural complications
R RTC TEAR, TENDONITIS AND WEAKNESS
|
0.00%
0/193 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
2.4%
1/41 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/78 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
Injury, poisoning and procedural complications
CLAVICLE FRACTURE AFTER FALL AT WORK
|
0.00%
0/193 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/78 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
1.7%
1/59 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
Blood and lymphatic system disorders
SPLENIC NECROSIS
|
0.52%
1/193 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/78 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
1.7%
1/59 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
Respiratory, thoracic and mediastinal disorders
PNEMOTHORAX- RIGHT
|
0.00%
0/193 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/78 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.74%
1/136 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
1.7%
1/59 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
Other adverse events
| Measure |
HEALICOIL™ PK Preloaded Suture Anchors
n=193 participants at risk
Participants who have received PEEK Suture Anchor:
HEALICOIL™ PK Preloaded Suture Anchors
|
BIORAPTOR™ 2.3 PK Suture Anchors/BIORAPTOR™ Curved 2.3 PK Suture Anchors
n=41 participants at risk
Participants who have received PEEK Suture Anchor:
BIORAPTOR™ 2.3 PK Suture Anchors/BIORAPTOR™ Curved 2.3 PK Suture Anchors
|
MULTIFIX™ S Ultra Knotless Fixation System
n=78 participants at risk
Participants who have received PEEK Suture Anchor:
MULTIFIX™ S Ultra Knotless Fixation System
|
FOOTPRINT™ Ultra PK Suture Anchors
n=136 participants at risk
Participants who have received PEEK Suture Anchor:
FOOTPRINT™ Ultra PK Suture Anchors
|
TWINFIX™ Ultra PK Suture Anchors/TWINFIX™ Ultra Preloaded and With Needles
n=57 participants at risk
Participants who have received PEEK Suture Anchor:
TWINFIX™ Ultra PK Suture Anchors/TWINFIX™ Ultra Preloaded and with Needles
|
SPEEDSCREW™ Knotless Fixation System
n=59 participants at risk
Participants who have received PEEK Suture Anchor:
SPEEDSCREW™ Knotless Fixation System
|
SpeedLock Knotless Fixation Device
n=18 participants at risk
Participants who have received PEEK Suture Anchor:
SpeedLock Knotless Fixation Device
|
|---|---|---|---|---|---|---|---|
|
General disorders
LEFT SHOULDER DULL PAIN AFTER STRENUOUS ACTIVITY
|
0.52%
1/193 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
1.3%
1/78 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
General disorders
COMPLEX REGIONAL PAIN SYNDROME TYPE II
|
0.00%
0/193 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
1.3%
1/78 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
General disorders
PAIN ON THE RIGHT SIDE OF HER SHOULDER DOWN HER NECK AND THE MEDIAL BORDER OF HER RIGHT SCAPULA.
|
0.00%
0/193 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/78 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
1.7%
1/59 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
General disorders
RIGHT SIDE ARM PAIN
|
0.00%
0/193 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/78 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
1.7%
1/59 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
General disorders
SHOULDER PAIN POST FALL
|
0.00%
0/193 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/78 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.74%
1/136 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
1.7%
1/59 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
General disorders
LEFT HAND NUMBNESS
|
0.00%
0/193 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/78 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.74%
1/136 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
Musculoskeletal and connective tissue disorders
LEFT SHOULDER TENDINITIS/BURSITIS
|
0.00%
0/193 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/78 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.74%
1/136 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
Injury, poisoning and procedural complications
RIGHT SHOULDER DISCOMFORT SECONDARY TO FALL
|
0.00%
0/193 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/78 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.74%
1/136 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
Musculoskeletal and connective tissue disorders
ADHESIVE CAPSULITIS
|
0.00%
0/193 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/78 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.74%
1/136 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
Skin and subcutaneous tissue disorders
LEFT SHOULDER ANTERIOR PORTAL REDDENED AND SWOLLEN WITH RESOLVING BICEP ECCHYMOSIS
|
0.00%
0/193 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/78 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.74%
1/136 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
General disorders
RIGHT SHOULDER PAIN
|
0.00%
0/193 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/78 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.74%
1/136 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
General disorders
CONTINUED LEFT SHOULDER WEAKNESS
|
0.00%
0/193 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/78 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.74%
1/136 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
General disorders
ACTIVE RANGE OF MOTION LIMITED BY PAIN
|
0.00%
0/193 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/78 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.74%
1/136 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
Musculoskeletal and connective tissue disorders
BICEPS ATROPHY
|
0.00%
0/193 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/78 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.74%
1/136 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
General disorders
SHOOTING PAIN DOWN LEFT ARM
|
0.00%
0/193 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/78 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.74%
1/136 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
General disorders
RIGHT HAND CONTUSION
|
0.00%
0/193 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/78 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.74%
1/136 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
Musculoskeletal and connective tissue disorders
ADHESIVE CAPSULITIS RIGHT SHOULDER
|
0.00%
0/193 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/78 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.74%
1/136 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
General disorders
INCREASE IN RIGHT SHOULDER PAIN
|
0.00%
0/193 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/78 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.74%
1/136 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
Cardiac disorders
NEW ONSET ATRIAL FIBRILLATION
|
0.00%
0/193 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/78 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.74%
1/136 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
General disorders
RIGHT ARM LIMITED ROM SECONDARY RIGHT SHOULDER PAIN FROM LIFTING INJURY
|
0.00%
0/193 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/78 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.74%
1/136 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
Musculoskeletal and connective tissue disorders
RIGHT BICEPS TENDONITIS
|
0.00%
0/193 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/78 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.74%
1/136 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
Musculoskeletal and connective tissue disorders
RIGHT SHOULDER ADHESIVE CAPSULITIS POST RCR
|
0.00%
0/193 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/78 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.74%
1/136 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
Musculoskeletal and connective tissue disorders
PAINFUL HERNIATED CERVICAL DISC WITH MYELOPATHY
|
0.00%
0/193 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/78 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.74%
1/136 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
General disorders
BILATERAL SHOULDER PAIN
|
0.00%
0/193 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/78 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.74%
1/136 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
General disorders
LEFT SHOULDER INCREASING PAIN
|
0.00%
0/193 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/78 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.74%
1/136 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
General disorders
LEFT SHOULDER CLICKING, NUMBNESS LEFT ARM, LEFT 4TH AND 5TH FINGERS
|
0.00%
0/193 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/78 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.74%
1/136 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
Psychiatric disorders
NIGHTMARES FROM PERCOCET
|
0.00%
0/193 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/78 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.74%
1/136 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
General disorders
INSOMNIA R/T LEFT SHOULDER PAIN
|
0.00%
0/193 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/78 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.74%
1/136 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
General disorders
LEFT SHOULDER PAIN WITH EXERCISING
|
0.00%
0/193 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/78 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.74%
1/136 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
General disorders
LEFT SHOULDER STIFFNESS
|
0.00%
0/193 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/78 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.74%
1/136 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
General disorders
LEFT SHOULDER SORENESS
|
0.00%
0/193 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/78 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.74%
1/136 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
Vascular disorders
EXACERBATION HYPERTENSION
|
0.00%
0/193 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/78 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.74%
1/136 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
Musculoskeletal and connective tissue disorders
BICEPS TENDONITIS RIGHT SHOULDER
|
0.00%
0/193 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/78 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.74%
1/136 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
General disorders
NUMBNESS RIGHT THUMB
|
0.00%
0/193 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/78 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.74%
1/136 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
General disorders
HERNIATED DISC WITH MYELOPATHY, CONTINUED RIGHT ARM WEAKNESS, RIGHT SCAPULA AREA AND SHOULDER PAIN
|
0.00%
0/193 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/78 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.74%
1/136 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
General disorders
WORSENING RIGHT SHOULDER PAIN AND SWELLING
|
0.00%
0/193 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/78 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.74%
1/136 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
Injury, poisoning and procedural complications
FALL CAUSING RIGHT SHOULDER FORCED ABDUCTION
|
0.00%
0/193 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/78 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.74%
1/136 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
General disorders
RIGHT SHOULDER SORENESS AT TIMES
|
0.00%
0/193 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/78 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.74%
1/136 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
Injury, poisoning and procedural complications
ROTATOR CUFF SPRAIN/STRAIN LEFT SHOULDER
|
0.00%
0/193 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/78 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
1.5%
2/136 • Number of events 2 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
General disorders
INSOMNIA SECONDARY TO RIGHT SHOULDER PAIN
|
0.00%
0/193 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/78 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.74%
1/136 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
Infections and infestations
LEFT HAND THIRD FINGER PARONYCHIA VERY PAINFUL AND TENDER
|
0.00%
0/193 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/78 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.74%
1/136 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
General disorders
POSTERIOR/LATERAL NUMBNESS RIGHT ARM
|
0.00%
0/193 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/78 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.74%
1/136 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
General disorders
RIGHT SHOULDER SWELLING
|
0.00%
0/193 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/78 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.74%
1/136 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
General disorders
PAINFUL ROM
|
0.00%
0/193 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/78 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.74%
1/136 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
Endocrine disorders
RECURRENT 6MM RIGHT RTC TEAR SECONDARY TO DIABETES AND SMOKING CAUSING POOR TISSUE QUALITY
|
0.00%
0/193 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/78 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.74%
1/136 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
General disorders
INCREASING RIGHT SHOULDER PAIN
|
0.00%
0/193 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/78 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.74%
1/136 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
Injury, poisoning and procedural complications
ROTATOR CUFF SPRAIN/STRAIN RIGHT SHOULDER
|
0.00%
0/193 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/78 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.74%
1/136 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
General disorders
CONTINUING SHOULDER PAIN
|
0.52%
1/193 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
4.9%
2/41 • Number of events 2 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
3.8%
3/78 • Number of events 3 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
General disorders
PAIN DOWN ARM TO LEFT HAND 4TH AND 5TH FINGERS
|
0.52%
1/193 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
1.3%
1/78 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
General disorders
LEFT SHOULDER BURSITIS
|
0.52%
1/193 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
1.3%
1/78 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
General disorders
LEFT SHOULDER PAIN WITH DECREASED ROM
|
0.52%
1/193 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
1.3%
1/78 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
General disorders
LEFT SHOULDER PAIN AFTER PT STRENGTHENING EXERCISES
|
0.52%
1/193 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
1.3%
1/78 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
Musculoskeletal and connective tissue disorders
LEFT LATERAL EPICONDYLITIS
|
1.0%
2/193 • Number of events 2 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
2.6%
2/78 • Number of events 2 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
Musculoskeletal and connective tissue disorders
LEFT TRICEPS TENDONITIS
|
0.52%
1/193 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
1.3%
1/78 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
General disorders
TINGLING FROM LEFT ELBOW TO WRIST
|
0.52%
1/193 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
1.3%
1/78 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
General disorders
LEFT ELBOW WARM TO TOUCH WITH DECREASED MOBILITY AND PAIN RADIATING TO WRIST
|
0.52%
1/193 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
1.3%
1/78 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
General disorders
SHOULDER PAIN
|
1.0%
2/193 • Number of events 2 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
9.8%
4/41 • Number of events 4 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
2.6%
2/78 • Number of events 2 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.74%
1/136 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
Injury, poisoning and procedural complications
INCREASED RIGHT SHOULDER PAIN R/T FALL
|
0.52%
1/193 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
1.3%
1/78 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
Injury, poisoning and procedural complications
RIGHT SHOULDER INCREASED PAIN AND STIFFNESS R/T CATCHING FALLING CLIENT
|
0.52%
1/193 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
1.3%
1/78 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
Injury, poisoning and procedural complications
RIGHT ANKLE SPRAIN WITH SWELLING AND PAIN R/T FALL
|
0.52%
1/193 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
1.3%
1/78 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
General disorders
RIGHT SHOULDER LIMITED ROM AND WEAKNESS
|
0.52%
1/193 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
1.3%
1/78 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
General disorders
INCREASED PAIN RIGHT ANKLE
|
0.52%
1/193 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
1.3%
1/78 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
General disorders
WORSENING PAIN RIGHT SHOULDER
|
0.00%
0/193 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
2.4%
1/41 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/78 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
Injury, poisoning and procedural complications
RIGHT SHOULDER IMPINGEMENT SYNDROME, WITH LIMITED ADLS AND NIGHT PAIN
|
0.52%
1/193 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
1.3%
1/78 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
Musculoskeletal and connective tissue disorders
NOCTURNAL AWAKENING DUE TO RIGHT SHOULDER TENDINOSIS
|
0.52%
1/193 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
1.3%
1/78 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
Infections and infestations
RIGHT SHOULDER SWELLING, REDNESS, WARMTH AND PAIN, CELLULITIS
|
0.52%
1/193 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
1.3%
1/78 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
General disorders
LEFT SHOULDER PAIN, STIFFNESS, NUMBNESS AND DECREASED SENSATION RELATED TO RECURRENT RTC TEAR
|
0.52%
1/193 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
1.3%
1/78 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
General disorders
RIGHT SHOULDER ACHING PAIN WITH CERTAIN MOVEMENTS
|
0.52%
1/193 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
1.3%
1/78 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
General disorders
LEFT SHOULDER MILD PAIN AND WEAKNESS
|
0.52%
1/193 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
1.3%
1/78 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
General disorders
DECREASED LEFT SHOULDER STRENGTH
|
0.52%
1/193 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
1.3%
1/78 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
General disorders
LEFT SHOULDER DECREASED ROM AND STRENGTH RELATED RTC RUPTURE
|
0.52%
1/193 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
1.3%
1/78 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
General disorders
LEFT SHOULDER CONSTANT PAIN AND WEAKNESS RELATED TO RECURRENT RTC TEAR
|
0.52%
1/193 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
1.3%
1/78 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
General disorders
LEFT ARM PAIN BICEP REGION AND LEFT SHOULDER SWELLING
|
0.52%
1/193 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
1.3%
1/78 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
Musculoskeletal and connective tissue disorders
SMALL PARTIAL THICKNESS LEFT SUPRASPINATUS TEAR
|
0.52%
1/193 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
1.3%
1/78 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
General disorders
OCCASIONAL SHOULDER PAIN
|
1.0%
2/193 • Number of events 2 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
7.3%
3/41 • Number of events 3 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/78 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
Gastrointestinal disorders
NAUSEA AND CONSTIPATION R/T POST-OP OXYCONTIN
|
0.52%
1/193 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
1.3%
1/78 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
Musculoskeletal and connective tissue disorders
DISCOMFORT RIGHT BICEP INTO NECK AND DISUSE ATROPHY
|
0.52%
1/193 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
1.3%
1/78 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
General disorders
RIGHT SHOULDER PAIN AND WEAKNESS
|
0.52%
1/193 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
1.3%
1/78 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
General disorders
INTERMITTENT LEFT SHOULDER PAIN SINCE EXERCISING
|
0.52%
1/193 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
1.3%
1/78 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
General disorders
INTERMITTENT EPISODES OF PERSPIRING AND FEELING OF EXHAUSTION
|
0.52%
1/193 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
1.3%
1/78 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
General disorders
LEFT SHOULDER DECREASED ROM
|
0.52%
1/193 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
1.3%
1/78 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
Gastrointestinal disorders
DIVERTICULITIS
|
0.52%
1/193 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
1.3%
1/78 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
General disorders
LEFT SHOULDER WEAKNESS AND PAIN
|
0.52%
1/193 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
1.3%
1/78 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
General disorders
INTERMITTENT LEFT BICEP PAIN AND CRAMPING
|
0.52%
1/193 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
1.3%
1/78 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
General disorders
INCREASED LUE PAIN WITH NUMBNESS AND TINGLING TO LEFT RADIAL DIGITS AND INSOMNIA RELATED TO PAIN
|
0.52%
1/193 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
1.3%
1/78 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
General disorders
INCREASING LEFT SHOULDER PAIN
|
0.52%
1/193 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
1.3%
1/78 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
Musculoskeletal and connective tissue disorders
LEFT SHOULDER BURSITIS WITH DECREASED ROM AND WEAKNESS
|
0.52%
1/193 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
1.3%
1/78 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
General disorders
THUMB PAIN
|
0.52%
1/193 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
1.3%
1/78 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
General disorders
LEFT SHOULDER PAIN AND RESIDUAL WEAKNESS
|
0.52%
1/193 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
1.3%
1/78 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
General disorders
LEFT SHOULDER PAIN, LTD. ROM, WEAKNESS, DISUSE ATROPHY
|
0.52%
1/193 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
1.3%
1/78 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
Injury, poisoning and procedural complications
LEFT RTC SMALL PARTIAL THICKNESS TEAR
|
0.52%
1/193 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
1.3%
1/78 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
General disorders
LEFT SHOULDER STIFFNESS, CONSTANT SORENESS, DECREASED ROM, ACHING AND WEAKNESS
|
0.52%
1/193 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
1.3%
1/78 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
General disorders
RIGHT ANTERIOR SHIN NEURALGIA/SPRAIN
|
0.52%
1/193 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
1.3%
1/78 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
General disorders
MIGRAINE HEADACHES
|
0.52%
1/193 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
1.3%
1/78 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
General disorders
OCCASIONAL DEEP LEFT SHOULDER PAIN
|
0.52%
1/193 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
1.3%
1/78 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
General disorders
LEFT ARM WEAKNESS
|
0.52%
1/193 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
1.3%
1/78 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
Gastrointestinal disorders
ABDOMINAL PAIN AND CONSTIPATION
|
0.52%
1/193 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
1.3%
1/78 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
General disorders
L SHOULDER PAIN W/LTD. ROM AND STRENGTH
|
0.52%
1/193 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
1.3%
1/78 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
Injury, poisoning and procedural complications
LEFT SHOULDER EDEMA
|
0.52%
1/193 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
1.3%
1/78 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
General disorders
INCREASED LEFT SHOULDER PAIN, HYPERSENSITIVITY AND PARASTHESIA, QUESTION POSSIBLE RSD
|
0.52%
1/193 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
1.3%
1/78 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
Infections and infestations
CELLULITIS AND PURULENT DRAINAGE LEFT SHOULDER WOUND
|
0.52%
1/193 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
1.3%
1/78 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
General disorders
INTERMITTENT LEFT SHOULDER PAIN
|
0.52%
1/193 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
1.3%
1/78 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
General disorders
RIGHT SHOULDER PAIN WITH DECREASED ROM
|
0.52%
1/193 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
1.3%
1/78 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
General disorders
RIGHT SHOULDER PAIN WITH TIGHTNESS, WEAKNESS, AND DECREASED ROM
|
0.52%
1/193 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
1.3%
1/78 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
Injury, poisoning and procedural complications
RECURRENT RTC TEAR
|
1.0%
2/193 • Number of events 2 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
2.6%
2/78 • Number of events 2 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
General disorders
INTERMITTENT RIGHT SHOULDER PAIN
|
0.00%
0/193 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
2.4%
1/41 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/78 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
Infections and infestations
LEFT SHOULDER ANTERIOR INCISIONS WITH MILD CELLULITIS
|
0.00%
0/193 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
2.4%
1/41 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/78 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
Injury, poisoning and procedural complications
WORSENING LEFT SHOULDER PAIN AND SWELLING DUE TO FALLING IN SHOWER, CATCHING HERSELF WITH LEFT ARM
|
0.00%
0/193 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
2.4%
1/41 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/78 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
General disorders
LEFT SHOULDER STIFFNESS AND LTD. ROM
|
0.00%
0/193 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
2.4%
1/41 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/78 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
Musculoskeletal and connective tissue disorders
LEFT SHOULDER MILD TENDINOSIS, POSSIBLE SLAP TEAR
|
0.00%
0/193 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
2.4%
1/41 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/78 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
Injury, poisoning and procedural complications
RIGHT ROTATOR CUFF TENDONITIS, ACJ IMPINGEMENT
|
0.00%
0/193 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
2.4%
1/41 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/78 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
General disorders
RIGHT SHOULDER SWELLING AND PAIN
|
0.00%
0/193 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
2.4%
1/41 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/78 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
General disorders
LEFT SHOULDER STIFFNESS "SLEPT ON IT WRONG"
|
0.00%
0/193 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
2.4%
1/41 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/78 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
General disorders
OCCASIONAL LEFT SHOULDER DECREASED ROM, PAIN, AND WEAKNESS
|
0.00%
0/193 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
2.4%
1/41 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/78 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
Injury, poisoning and procedural complications
SLIPPED OFF CURB AND FELL ONTO LEFT ARM
|
0.00%
0/193 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
2.4%
1/41 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/78 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
Injury, poisoning and procedural complications
PAIN FROM LEFT SHOULDER STRAIN
|
0.00%
0/193 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
2.4%
1/41 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/78 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
General disorders
RETURNING LEFT SHOULDER PAIN
|
0.00%
0/193 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
2.4%
1/41 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/78 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
General disorders
R SHOULDER PAIN, DECREASED ROM AND BICEPS AREA PAIN
|
0.00%
0/193 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
2.4%
1/41 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/78 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
Injury, poisoning and procedural complications
RIGHT SHOULDER SURGICAL SCAR SENSITIVITY
|
0.00%
0/193 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
2.4%
1/41 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/78 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
Musculoskeletal and connective tissue disorders
PALPABLE TIGHTNESS RIGHT TRAPEZIUS AREA
|
0.00%
0/193 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
2.4%
1/41 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/78 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
General disorders
LEFT SHOULDER INTERMITTENT PAIN AND DECREASED ROM
|
0.00%
0/193 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
2.4%
1/41 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/78 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
General disorders
CONTINUING RIGHT SHOULDER PAIN AND DECREASED ROM
|
0.00%
0/193 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
2.4%
1/41 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/78 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
General disorders
REACHING IN PT AND FELT A "POP" WITH INCREASED PAIN RIGHT SHOULDER
|
0.00%
0/193 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
2.4%
1/41 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/78 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
Skin and subcutaneous tissue disorders
RAISED RASH RIGHT FOREARM AND RIGHT ARMPIT
|
0.00%
0/193 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
2.4%
1/41 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/78 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
Gastrointestinal disorders
NAUSEA FROM PAIN MEDICATION
|
0.00%
0/193 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
2.4%
1/41 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/78 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
Injury, poisoning and procedural complications
REDNESS AND SWELLING AROUND INCISION FRONT OF RIGHT SHOULDER
|
0.00%
0/193 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
2.4%
1/41 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/78 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
Injury, poisoning and procedural complications
RIGHT BICIPITAL GROOVE TENDERNESS AFTER OVERSTRETCHING IN PT
|
0.00%
0/193 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
2.4%
1/41 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/78 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
Musculoskeletal and connective tissue disorders
GLENOHUMERAL INTERNAL ROTATION DEFICIT RIGHT SHOULDER
|
0.00%
0/193 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
2.4%
1/41 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/78 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
General disorders
LEFT SHOULDER CONTINUING PAIN
|
0.00%
0/193 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
2.4%
1/41 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/78 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
Musculoskeletal and connective tissue disorders
LEFT SHOULDER STIFFNESS
|
0.00%
0/193 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
2.4%
1/41 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/78 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
Gastrointestinal disorders
WORSENING LEFT SHOULDER PAIN AND DECREASED ROM
|
0.00%
0/193 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
2.4%
1/41 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/78 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
Musculoskeletal and connective tissue disorders
LEFT KNEE ARTHROFIBROSIS
|
0.00%
0/193 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
2.4%
1/41 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/78 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
General disorders
RIGHT SHOULDER PAIN AT NIGHT
|
0.00%
0/193 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
2.4%
1/41 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/78 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
Injury, poisoning and procedural complications
CONTINUED POST-OP REVISION LEFT SHOULDER PAIN
|
0.00%
0/193 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
2.4%
1/41 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/78 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
Injury, poisoning and procedural complications
POSSIBLE LEFT CUBITAL TUNNEL SYNDROME
|
0.00%
0/193 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
2.4%
1/41 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/78 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
General disorders
LEFT SHOULDER POST. INCISION OPEN W/BLOOD DRAINAGE- SUTURE FELL OUT
|
0.00%
0/193 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
2.4%
1/41 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/78 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
General disorders
LEFT SHOULDER WORSENING PAIN, LTD ROM
|
0.00%
0/193 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
2.4%
1/41 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/78 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
Nervous system disorders
ULNAR NERVE SYMPTOMS AND MEDIAL SCAPULAR PAIN, NECK PAIN
|
0.00%
0/193 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
2.4%
1/41 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/78 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
Nervous system disorders
HERNIATED DISC WITH MYELOPATHY
|
0.00%
0/193 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
2.4%
1/41 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/78 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
General disorders
RECURRING RIGHT ELBOW PAIN, ACUTE RIGHT EPICONDYLITIS
|
0.00%
0/193 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
2.4%
1/41 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/78 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
General disorders
L SHOULDER PAIN, DECREASED ROM W/DIFFICULTY SLEEPING @ NIGHT, POSSIBLE ADHESIVE CAPSULITIS
|
0.00%
0/193 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
2.4%
1/41 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/78 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
General disorders
LEFT ELBOW PAIN
|
0.00%
0/193 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
2.4%
1/41 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/78 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
Musculoskeletal and connective tissue disorders
LEFT ELBOW STIFFNESS
|
0.00%
0/193 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
2.4%
1/41 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/78 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
General disorders
RIGHT FOREARM PAIN AND MUSCLE SPASMS
|
0.00%
0/193 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
2.4%
1/41 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/78 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
General disorders
RIGHT SHOULDER INSTABILITY AND PAIN R/T STRAIN/SPRAIN
|
0.00%
0/193 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
2.4%
1/41 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/78 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
Injury, poisoning and procedural complications
LEFT SHOULDER PAIN POST MUA, LOA
|
0.00%
0/193 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
2.4%
1/41 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/78 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
General disorders
RECURRENT RIGHT SHOULDER PAIN, POST-OP REVISION
|
0.00%
0/193 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
2.4%
1/41 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/78 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
Musculoskeletal and connective tissue disorders
RIGHT SHOULDER MUSCLE SPASMS
|
0.00%
0/193 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
2.4%
1/41 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/78 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
Injury, poisoning and procedural complications
RIGHT ROTATOR CUFF RE-TEAR
|
0.52%
1/193 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/78 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
Injury, poisoning and procedural complications
ROTATOR CUFF RETEAR
|
0.00%
0/193 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/78 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
1.8%
1/57 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
Nervous system disorders
SEVERE CENTRAL SPINAL STENOSIS
|
0.00%
0/193 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/78 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
1.8%
1/57 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
Skin and subcutaneous tissue disorders
HERPES ZOSTER
|
0.00%
0/193 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/78 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
1.8%
1/57 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
Blood and lymphatic system disorders
HYPERLIPIDEMIA
|
0.00%
0/193 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/78 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
1.8%
1/57 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
Psychiatric disorders
GENERALIZED ANXIETY DISORDER
|
0.00%
0/193 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/78 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
1.8%
1/57 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
Injury, poisoning and procedural complications
RIGHT ELBOW INJURY, POSSIBLE FRACTURE, OCCURRED DUE TO FALL
|
0.00%
0/193 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/78 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
1.8%
1/57 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
Musculoskeletal and connective tissue disorders
MASS OF SOFT TISSUE OF RIGHT UPPER EXTREMITY
|
0.52%
1/193 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/78 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
1.8%
1/57 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
Psychiatric disorders
ADD
|
0.52%
1/193 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/78 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.74%
1/136 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
1.8%
1/57 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
Blood and lymphatic system disorders
HYPERTENSION
|
0.52%
1/193 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/78 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.74%
1/136 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
1.8%
1/57 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
Infections and infestations
INFECTION/SMALL HEMATOMA
|
0.52%
1/193 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/78 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/59 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
|
Injury, poisoning and procedural complications
ROTATOR CUFF FAILURE / RECURRENT TEAR
|
0.00%
0/193 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/41 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/78 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/136 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/57 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
1.7%
1/59 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
0.00%
0/18 • Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60