MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-03-05 for HUNTER TENDON ROD manufactured by Wright Medical Technology.
[15560064]
Md removed hunter tendon rod- stated failure of device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5010237 |
| MDR Report Key | 1338242 |
| Date Received | 2009-03-05 |
| Date of Report | 2009-03-05 |
| Date of Event | 2008-09-04 |
| Date Added to Maude | 2009-03-17 |
| 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 | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HUNTER TENDON ROD |
| Generic Name | HUNTER TENDON ROD |
| Product Code | HXA |
| Date Received | 2009-03-05 |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WRIGHT MEDICAL TECHNOLOGY |
| Manufacturer Address | 5677 AIRLINE ROAD ARLINGTON TN 38002 US 38002 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2009-03-05 |