MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-08-22 for UNIVERSAL 2 TOTAL WRIST IMPLANT * manufactured by Kmi, Inc..
[304263]
Breakage of carpal component of universal 2 total wrist implant. Implant fracture through the carpal component stem. Was noted approximately one year post op for the first time, but may have been present earlier.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1029402 |
| MDR Report Key | 481387 |
| Date Received | 2003-08-22 |
| Date of Report | 2003-08-22 |
| Date of Event | 2003-08-11 |
| Date Added to Maude | 2003-09-05 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNIVERSAL 2 TOTAL WRIST IMPLANT |
| Generic Name | TOTAL WRIST IMPLANT |
| Product Code | KWM |
| Date Received | 2003-08-22 |
| Model Number | UNIVERSAL 2 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 470274 |
| Manufacturer | KMI, INC. |
| Manufacturer Address | * SAN DIEGO CA * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2003-08-22 |