FDA Adverse Event
Injury
Summary report: N
TIE-IN TRAPEZIUM IMPLANT
MDR report key: 1352385
·
Received March 26, 2009
Report
- Report Number
- 1043534-2009-00094
- Event Type
- Injury
- Date Received
- March 26, 2009
- Date of Event
- February 16, 2009
- Report Date
- March 23, 2009
- Manufacturer
- WRIGHT MEDICAL TECHNOLOGY, INC.
- Product Code
- KYI
- PMA / PMN Number
- K033529
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. THE DEVICE EVENT CODE IS ADDRESSED IN THE PACKAGE INSERT. THIS REPORT WILL BE UPDATED, WHEN THE INVESTIGATION IS COMPLETE. THIS EVENT OCCURRED IN GERMANY.
Description of Event or Problem · 1
ALLEGEDLY IMPLANT WAS REMOVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TIE-IN TRAPEZIUM IMPLANT | KYI | WRIGHT MEDICAL TECHNOLOGY, INC. | NA | 127514178 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | Hospitalization| R |