FDA Adverse Event
Injury
Summary report: N
*
MDR report key: 129328
·
Received October 17, 1997
Report
- Report Number
- 129328
- Event Type
- Injury
- Date Received
- October 17, 1997
- Date of Event
- October 7, 1997
- Report Date
- October 15, 1997
- Manufacturer
- UNK
- Product Code
- KIG
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
PT HAD PAIN AND DEFORMITY OF LEFT WRIST. SURGERY DONE TO REPLACE SILASTIC WRIST IMPLANT. IMPLANT FOUND TO BE FRACTURED COMPLETELY AT DISTAL EXTENSION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | * Implant | SILASTIC WRIST IMPLANT | KIG | UNK | UNK | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Disability |