MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2007-06-18 for X-WIRE 80131 manufactured by Orthofix Inc..
[655327]
Approximately 30 days post surgery during a follow up visit, the doctor found that two x-wires were broken. The wires were removed from the treatment site and discarded in the doctor's office.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183449-2007-00009 |
| MDR Report Key | 866741 |
| Report Source | 08 |
| Date Received | 2007-06-18 |
| Date of Report | 2007-06-15 |
| Date of Event | 2007-05-02 |
| Date Mfgr Received | 2007-05-02 |
| Date Added to Maude | 2008-02-13 |
| 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 | ALMA RELJA, ASSOCIATE |
| Manufacturer Street | 1720 BRAY CENTRAL DR. |
| Manufacturer City | MCKINNEY TX 75002 |
| Manufacturer Country | US |
| Manufacturer Postal | 75002 |
| Manufacturer Phone | 4697428885 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | X-WIRE |
| Generic Name | X-WIRE |
| Product Code | NDK |
| Date Received | 2007-06-18 |
| Model Number | 80131 |
| Catalog Number | 80131 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 959698 |
| Manufacturer | ORTHOFIX INC. |
| Manufacturer Address | MCKINNEY TX US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-06-18 |