MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 02,05 report with the FDA on 2013-02-11 for NONE manufactured by Synthes (usa).
[3332447]
Pt participated in a (b)(4) at vertebral levels 1, 2, 3, or 4 to evaluate the clinical and radiographic outcomes in pts diagnosed with cervical degenerative disc disease (ddd) between c2 - c7. Preoperative diagnosis was symptoms of radiculopathy. Pt was implanted with a vectra-t cervical plate and a cc acf spacer at levels c3 c4, c4 c5, c5 c6, c6 c7 with pedicle screws at c3, c4, c5, c6, and c7. Pt had been experiencing pain for 1 month. Surgery date was (b)(6) 2007 and postoperatively, pt experienced weakness in fingers, requiring pt. This is report 9 of 11 for this event.
Patient Sequence No: 1, Text Type: D, B5
[10476296]
Synthes is submitting this report as a result of remediation activities related to fda warning letter dated (b)(4) 2012. Device(s) listed in this report is (are) used for treatment, not diagnosis. Any add'l info received regarding this event after filing this report shall be filed on a supplemental report. 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 | 2520274-2013-10056 |
| MDR Report Key | 2961319 |
| Report Source | 02,05 |
| Date Received | 2013-02-11 |
| Date of Report | 2007-12-29 |
| Date Mfgr Received | 2013-01-12 |
| Date Added to Maude | 2013-04-24 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | NONE |
| Product Code | KWO |
| Date Received | 2013-02-11 |
| 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) |
| Manufacturer Address | WEST CHESTER PA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-02-11 |