FDA Adverse Event
Injury
Summary report: N
EQUINOXE REVERSE GLENOID PLATE
MDR report key: 6072396
·
Received November 2, 2016
Report
- Report Number
- 1038671-2016-00745
- Event Type
- Injury
- Date Received
- November 2, 2016
- Date of Event
- October 20, 2016
- Report Date
- October 6, 2017
- Manufacturer
- EXACTECH, INC
- Product Code
- KWT
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE CONTRIBUTION OF THE DEVICES TO THE EXPERIENCE REPORTED COULD NOT BE DETERMINED AS THE DEVICES WERE NOT RETURNED FOR EVALUATION. ADDITIONALLY, THE DEVICE SPECIFIC INFORMATION WAS NOT PROVIDED, PRECLUDING A REVIEW OF THE DEVICE HISTORY RECORD.
Additional Manufacturer Narrative · 1
VOID THIS SUBMISSION.
Description of Event or Problem · 1
REVISION DUE TO ACUTE DISLOCATION. THE CASE REPORT FORM INDICATES THE EVENT IS POSSIBLY RELATED TO DEVICES AND DEFINITELY RELATED TO PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES.
Description of Event or Problem · 1
VOID THIS SUBMISSION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 723156 | EQUINOXE REVERSE GLENOID PLATE | GLENOID PLATE | KWT | EXACTECH, INC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Required Intervention |