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).
[3135281]
Pt participated in a multi-center, 4-arm study 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 8 of 11 for this event.
Patient Sequence No: 1, Text Type: D, B5
[10459080]
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 | 2520274-2013-10055 |
| MDR Report Key | 2961320 |
| 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 | 2013-04-23 |
| 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 | 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 |