MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2013-09-15 for manufactured by Synthes (usa) West Chester, Pa.
[3806567]
It was reported that there were two nfix ii, n-hance product complaints. It was further reported that a portion of the devices from one of the two surgeries has been retrieved, but had not yet been received by synthes for analysis. No further information was provided. This is report 1 of 1 for complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[11092800]
Device was used for treatment. Actual event date not known. Exact part number could not be identified. The device is not being returned for evaluation. As no lot number was provided, no device history record review can be performed. There is no further information available on this event and no further investigation can be performed. Placeholder.
Patient Sequence No: 1, Text Type: N, H10
[28486779]
Note: blank fields on this form indicate information that is unknown, unavailable or unchanged. (b)(4)
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2520274-2013-01610 |
| MDR Report Key | 3348498 |
| Report Source | 07 |
| Date Received | 2013-09-15 |
| Date of Report | 2008-04-08 |
| Date Mfgr Received | 2008-04-08 |
| Date Added to Maude | 2013-12-20 |
| 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 | T. MCCARRON |
| 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 |
| Product Code | MCV |
| Date Received | 2013-09-15 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES (USA) WEST CHESTER, PA |
| Manufacturer Address | PA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-09-15 |