MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2012-05-03 for PINS/WIRES manufactured by Synthes Usa.
[17411381]
A pt was tested on an unk date for an acromion fracture with tension wires and screws. Subsequently, the pt returned to the surgeon complaining of pain. Examination and x-rays revealed a non-union of the acromion. The pt was returned to the operating room for removal of all hardware, which was reportedly intact. The pt was revised to two (2) 2. 7mm locking compression plates and screws. This report is #3 of 3 for the same event.
Patient Sequence No: 1, Text Type: D, B5
[17751534]
Investigation could not be completed, no conclusion could be drawn as no device was returned and no lot number was provided.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2520274-2012-00737 |
| MDR Report Key | 2572762 |
| Report Source | 05,07 |
| Date Received | 2012-05-03 |
| Date of Report | 2012-04-09 |
| Date Mfgr Received | 2012-04-09 |
| Date Added to Maude | 2012-05-15 |
| 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 | JODI TEMPLE |
| Manufacturer Street | 1302 WRIGHTS LANE E. |
| 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 |
| Brand Name | PINS/WIRES |
| Generic Name | PINS/WIRES |
| Product Code | DZK |
| Date Received | 2012-05-03 |
| 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 | 2012-05-03 |