MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2012-11-09 for WIRE/PIN manufactured by Synthes Usa.
[21673965]
The consultant reports regarding an incident whereby, postoperatively, a patient implanted with a mandible multi-vector distractor pulled a k wire pin(s), unknown how many, out of the mandible when the towel the patient was using on the facial area, snagged the device. There was no injury to the patient noted however, the pin(s) did need to be replaced.
Patient Sequence No: 1, Text Type: D, B5
[21888639]
Without a lot number the device history records review could not be completed. The investigation could not be completed; no conclusion could be drawn, as no product was received.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2520274-2012-03034 |
| MDR Report Key | 2827208 |
| Report Source | 05,07 |
| Date Received | 2012-11-09 |
| Date of Report | 2012-10-12 |
| Date Mfgr Received | 2012-10-12 |
| Date Added to Maude | 2012-11-09 |
| 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 | SHERRY LAING |
| 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 | WIRE/PIN |
| Product Code | DZK |
| Date Received | 2012-11-09 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES USA |
| Manufacturer Address | WEST CHESTER PA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2012-11-09 |