MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2006-10-04 for X-WIRE 2X450MM 80124 manufactured by Orthofix Srl.
[16027270]
The sheffield frame was applied on the pt's right foot for the treatment of charcot foot. During the treatment a wire broke between the 1st metatarsal and frame. The dr removed the wire and replaced it with a new one and another wire was inserted as a support. No compression was lost and the pt continued treatment with the frame.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183449-2006-00013 |
| MDR Report Key | 856290 |
| Report Source | 07 |
| Date Received | 2006-10-04 |
| Date of Report | 2006-09-22 |
| Date Mfgr Received | 2006-09-19 |
| Date Added to Maude | 2007-05-30 |
| 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 | 0 |
| Manufacturer Contact | ALMA RELJA |
| Manufacturer Street | 1720 BRAY CENTRAL DR |
| Manufacturer City | MCKINNEY TX 75069 |
| Manufacturer Country | US |
| Manufacturer Postal | 75069 |
| Manufacturer Phone | 4697428885 |
| Manufacturer G1 | ORTHOFIX SRL |
| Manufacturer Street | VIA DELLA NAZIONI 9 |
| Manufacturer City | BUSSOLENGO (VR) 37012 |
| Manufacturer Country | * |
| Manufacturer Postal Code | 37012 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | X-WIRE 2X450MM |
| Generic Name | EXTERNAL FIXATION |
| Product Code | NDK |
| Date Received | 2006-10-04 |
| Model Number | 80124 |
| Catalog Number | 80124 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Implant Flag | Y |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 841086 |
| Manufacturer | ORTHOFIX SRL |
| Manufacturer Address | * VERONA IT |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-10-04 |