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 |