MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2012-05-10 for CABLE/WIRE manufactured by Synthes (usa).
[2649753]
Pt treated with plate and screw fixation for distal femur fracture, returned to surgeon on unk date complaining of pain. X-rays showed a non-union of the distal femur along with 4 broken cortical screws, a conical screw that was backing out and an unk broken wire/cable. Pt was returned to the operating room on (b)(6) 2012 for hardware removal of the plate, 7 screws and wire/cable. Pt was revised to a longer plate bone graft. This is the 7th of 7 reports submitted on this event.
Patient Sequence No: 1, Text Type: D, B5
[9852078]
Investigation is ongoing; no conclusion could be drawn as no device was returned or part number or lot number provided.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2520274-2012-00779 |
| MDR Report Key | 2575875 |
| Report Source | 05,07 |
| Date Received | 2012-05-10 |
| Date of Report | 2012-04-13 |
| Date Mfgr Received | 2012-04-13 |
| Date Added to Maude | 2012-05-17 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | CHARISSE BALL |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 8006207025 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | CABLE/WIRE |
| Product Code | DZK |
| Date Received | 2012-05-10 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES (USA) |
| Manufacturer Address | WEST CHESTER PA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2012-05-10 |