MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,07 report with the FDA on 2012-06-04 for PINS/WIRES manufactured by .
[2785897]
The manager, market development, trauma reported surgeon submitted a presentation, "nonunion" failure of a fracture to heal, failure of advancing healing for approval. It showcases ten patients, various collected cases on the topic of nonunions. Patient #9: a female patient experienced a left femur fracture and was implanted with an angled blade plate and screws on an unknown date. X-rays on (b)(6) 2004 showed an non-union and three (3) screws pulled out. Patient was returned to the operating room on an unknown date and the 3 screws were removed and surgeon used cerclage wire to hold the plate. Eventually the entire construct was removed, unknown date, and the patient was revised to a straight plate. It can not be verified if the product is synthes product. This is 5 of 5 reports for this event.
Patient Sequence No: 1, Text Type: D, B5
[9825168]
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 | 2520274-2012-00974 |
| MDR Report Key | 2603458 |
| Report Source | 00,07 |
| Date Received | 2012-06-04 |
| Date of Report | 2010-10-01 |
| Date Mfgr Received | 2010-10-01 |
| Date Added to Maude | 2012-06-08 |
| 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 | MS 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 | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | PINS/WIRES |
| Product Code | DZK |
| Date Received | 2012-06-04 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2012-06-04 |