MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-07-13 for TRANSL AXIALIF FIXATION WIRE TRI-2207 manufactured by Transl.
[1167497]
Fixation wire broke, and we could not retrieve the wire during a minimally invasive axialif procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5011908 |
| MDR Report Key | 1414225 |
| Date Received | 2009-07-13 |
| Date of Report | 2009-07-13 |
| Date of Event | 2009-07-08 |
| Date Added to Maude | 2009-07-23 |
| 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 |
| 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 | TRANSL AXIALIF FIXATION WIRE |
| Generic Name | FIXATION WIRE |
| Product Code | DZK |
| Date Received | 2009-07-13 |
| Returned To Mfg | 2009-07-08 |
| Model Number | TRI-2207 |
| Lot Number | 043F06309 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TRANSL |
| Manufacturer Address | WILMINGTON NC US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2009-07-13 |