FDA Adverse Event
Injury
Summary report: N
EQUINOXE SHOULDER SYSTEM
MDR report key: 3981451
·
Received July 25, 2014
Report
- Report Number
- 1038671-2014-00297
- Event Type
- Injury
- Date Received
- July 25, 2014
- Report Date
- July 23, 2014
- Manufacturer
- EXACTECH, INC.
- Product Code
- KWS
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES. THE CONTRIBUTION OF THE DEVICES TO THE EXPERIENCE REPORTED COULD NOT BE DETERMINED AS THE DEVICES WERE NOT RETURNED FOR EVALUATION.
Description of Event or Problem · 1
PATIENT PRESENTS WITH SCAPULAR SPINE FRACTURE FROM FALL RESULTING IN POSSIBLE PERSISTENT PROBLEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 436645 | EQUINOXE SHOULDER SYSTEM | SHOULDER SYSTEM | KWS | EXACTECH, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 145 YR | Other |