MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2013-03-24 for manufactured by Synthes (usa) West Chester, Pa.
[3258088]
A presentation of the noteworthy radiographic observations of patients treated with synthes nflex implants reported an additional case of a possible unknown quantity of screw toggle for patient id (b)(6). The case will be monitored as additional follow-up visits are received. No further information was provided.
Patient Sequence No: 1, Text Type: D, B5
[10679231]
This 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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2520274-2013-01682 |
| MDR Report Key | 3018701 |
| Report Source | 07 |
| Date Received | 2013-03-24 |
| Date of Report | 2008-08-28 |
| Date Mfgr Received | 2008-08-28 |
| Date Added to Maude | 2013-05-23 |
| 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 | 3 |
| 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 | 2013-03-24 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2013-03-24 |