MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2008-10-16 for HUNTER TENDON ROD TR30-0000 manufactured by Wright Medical Technology, Inc..
[21783853]
Allegedly rod was revised.
Patient Sequence No: 1, Text Type: D, B5
[21821251]
Investigation is not complete. Product was not returned for evaluation. Device event code is addressed in the package insert. Additional information has been requested. Although several attempts have been made, a medwatch 3500a has not been received from the user facility. Trends will be evaluated. This report will be updated when the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1043534-2008-00303 |
| MDR Report Key | 1199960 |
| Report Source | 05,07 |
| Date Received | 2008-10-16 |
| Date of Report | 2008-09-16 |
| Date of Event | 2008-09-04 |
| Date Facility Aware | 2008-09-04 |
| Date Mfgr Received | 2008-09-16 |
| Device Manufacturer Date | 2004-05-01 |
| Date Added to Maude | 2008-10-23 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | SUSAN ANDERSON |
| Manufacturer Street | 5677 AIRLINE ROAD |
| Manufacturer City | ARLINGTON TN 38002 |
| Manufacturer Country | US |
| Manufacturer Postal | 38002 |
| Manufacturer Phone | 9018674140 |
| Manufacturer G1 | WRIGHT MEDICAL TECHNOLOGY, INC. |
| Manufacturer Street | 5677 AIRLINE ROAD |
| Manufacturer City | ARLINGTON TN 38002 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38002 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HUNTER TENDON ROD |
| Product Code | HXA |
| Date Received | 2008-10-16 |
| Model Number | NA |
| Catalog Number | TR30-0000 |
| Lot Number | 05483969 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 4 MO |
| Device Eval'ed by Mfgr | * |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 1248240 |
| Manufacturer | WRIGHT MEDICAL TECHNOLOGY, INC. |
| Manufacturer Address | ARLINGTON TN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2008-10-16 |