MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2008-11-13 for TRUE/LOK EXTERNAL FIXATION SYSTEM WIRE 54-1215 manufactured by Orthofix Inc..
[1012639]
Provided information states that wire breakage was detected 26 days after the initial procedure. Patient had a second procedure to replace the broken wires.
Patient Sequence No: 1, Text Type: D, B5
[8164679]
The device was discarded at the user facility, therefore evaluation by the manufacturer is not possible.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2183449-2008-00011 |
| MDR Report Key | 1264642 |
| Report Source | 07 |
| Date Received | 2008-11-13 |
| Date of Report | 2008-11-13 |
| Date of Event | 2008-10-20 |
| Date Mfgr Received | 2008-10-28 |
| Date Added to Maude | 2009-08-07 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | RANDALL WHEELAND, DIRECTOR |
| Manufacturer Street | 1720 BRAY CENTRAL DR. |
| Manufacturer City | MCKINNEY TX 75069 |
| Manufacturer Country | US |
| Manufacturer Postal | 75069 |
| Manufacturer Phone | 4697422529 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRUE/LOK EXTERNAL FIXATION SYSTEM WIRE |
| Generic Name | FIXATION WIRE, 1.8MM X 400MM |
| Product Code | DZK |
| Date Received | 2008-11-13 |
| Model Number | 54-1215 |
| Catalog Number | 54-1215 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORTHOFIX INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2008-11-13 |