MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2014-09-23 for HUNTER TENDON ROD TR40-0000 manufactured by Wright Medical Technology, Inc..
[4911319]
Allegedly the implanted was expired, the issue was resolved by using a new implant.
Patient Sequence No: 1, Text Type: D, B5
[12396073]
Investigation not complete. Product has not been returned. Trends will be evaluated. This report will be updated when the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1043534-2014-00153 |
| MDR Report Key | 4146767 |
| Report Source | 07 |
| Date Received | 2014-09-23 |
| Date of Report | 2014-09-04 |
| Date of Event | 2014-09-04 |
| Date Mfgr Received | 2014-09-04 |
| Date Added to Maude | 2014-10-08 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | AMANDA CLARK |
| Manufacturer Street | 1023 CHERRY ROAD |
| Manufacturer City | MEMPHIS TN 38117 |
| Manufacturer Country | US |
| Manufacturer Postal | 38117 |
| Manufacturer Phone | 9018674140 |
| Manufacturer G1 | WRIGHT MEDICAL TECHNOLOGY, INC. |
| Manufacturer Street | 11576 MEMPHIS ARLINGTON ROAD |
| Manufacturer City | ARLINGTON TN 38002 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38002 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HUNTER TENDON ROD |
| Generic Name | SMALL JOINT COMPONENT |
| Product Code | HXA |
| Date Received | 2014-09-23 |
| Catalog Number | TR40-0000 |
| Lot Number | 067449112 |
| Operator | OTHER |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WRIGHT MEDICAL TECHNOLOGY, INC. |
| Manufacturer Address | ARLINGTON TN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-09-23 |