MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-04-18 for KMI TOTAL WRIST IMPLANT KMI UNIVERSAL 2 manufactured by Integra Lifescienses Corporation.
[16404755]
In 2008, total wrist implant fractured requiring repair. Pt returned to or for damaged hardware to be removed and replaced.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5006300 |
| MDR Report Key | 1031612 |
| Date Received | 2008-04-18 |
| Date of Report | 2008-02-20 |
| Date of Event | 2008-02-20 |
| Date Added to Maude | 2008-04-28 |
| 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 | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KMI TOTAL WRIST IMPLANT |
| Generic Name | ORTHOPEDIC PRODUCTS |
| Product Code | KWM |
| Date Received | 2008-04-18 |
| Model Number | KMI UNIVERSAL 2 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 1000468 |
| Manufacturer | INTEGRA LIFESCIENSES CORPORATION |
| Manufacturer Address | 311 ENTERPRISE DR PLAINSBORO NJ 08536 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2008-04-18 |