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 |