MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2014-04-22 for IMPLANT, FIXATION DEVICE, SPINAL manufactured by Synthes (usa).
[16914567]
It was reported that three of the four locking screws and locking caps are coming loose on a patient? S c6-t2 construct on the right side postoperatively. Non-union, delayed healing has been reported. The loosening of the screws and caps at c6-t1 was confirmed on imaging. Revision surgery was performed on (b)(6) 2014; the surgeon removed six out of the eight locking screws and replaced them with six new screws, the rod were replaced as well. The remaining two screws of the original construct were determined by the surgeon to be functioning properly and were intact, hence were not removed. This report is for one unknown rod. This is report 5 of 5 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[16942204]
This report is for 1 unknown rod/unknown lot. 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. Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2520274-2014-11009 |
| MDR Report Key | 3765313 |
| Report Source | 05,07 |
| Date Received | 2014-04-22 |
| Date of Report | 2014-03-31 |
| Date Mfgr Received | 2014-03-31 |
| Date Added to Maude | 2014-04-22 |
| 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 | LINDA PLEWS |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | IMPLANT, FIXATION DEVICE, SPINAL |
| Product Code | JDN |
| Date Received | 2014-04-22 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES (USA) |
| Manufacturer Address | 1302 WRIGHTS LANE EAST WEST CHESTER PA 19380 US 19380 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-04-22 |