MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 2013-12-19 for CERVIC-SPINE-SCR ?4 DYNAM SELF-DRILL L16 04.613.716 manufactured by Synthes Gmbh.
[18301855]
Device report from synthes (b)(4) reports and event in (b)(6) as follows: it was reported during an unknown surgery on (b)(6) 2013, that after a vectra plate was placed, the fixation pins were not placed in the affected screw hole. The surgeon reported that the ring was broken and fragments were observed. It was also reported that the surgery was delayed for 30 minutes and no patient impact resulted. This report is 3 of 3 for complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[18399075]
Investigation could not be completed and no conclusion could be drawn as no device was returned and no lot number or part number was provided. Placeholder.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2520274-2013-07879 |
| MDR Report Key | 3527924 |
| Report Source | 01,05,07 |
| Date Received | 2013-12-19 |
| Date of Report | 2013-11-26 |
| Date of Event | 2013-11-25 |
| Date Mfgr Received | 2013-11-26 |
| Date Added to Maude | 2014-03-31 |
| 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 | GRISELDA WEBSTER |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 8006207025 |
| Manufacturer G1 | SYNTHES GMBH |
| Manufacturer Street | EIMATTSTRASSE 3 CH-4436 |
| Manufacturer City | OBERDORF |
| Manufacturer Country | SZ |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CERVIC-SPINE-SCR ?4 DYNAM SELF-DRILL L16 |
| Product Code | KWO |
| Date Received | 2013-12-19 |
| Catalog Number | 04.613.716 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES GMBH |
| Manufacturer Address | EIMATTSTRASSE 3 CH-4436 OBERDORF SZ |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-12-19 |