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 2013-10-16 for C2 NERVEMONITOR 05.662.001 manufactured by Synthes Gmbh.
[3917141]
Device report from synthes (b)(6) reports an event in (b)(6) as follows: surgeon performed a lateral surgery on l5-l3 with, (intra-operative neuro-monitor machine), c2 nerve monitor and the oracle cage system. The c2 nerve monitor was tested before surgery with demopatient. Signals and were normal. During the surgery the stimulation field turned yellow (stimulation was working) but it was not possible to receive a muscle reaction. In addition, an error message showed up. The surgery was then performed without neuro-monitoring. It was reported product occurrence was not relevant to the health of patient. This is 1 of 1 report for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[11161905]
This device used for diagnosis. Device is not distributed in the united states, but is similar to device marketed in the usa. The device was received and is entering the complaint system. A device history records review has been requested.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8030965-2013-05034 |
| MDR Report Key | 3414613 |
| Report Source | 01,05,07 |
| Date Received | 2013-10-16 |
| Date of Report | 2013-09-19 |
| Date of Event | 2013-09-09 |
| Date Mfgr Received | 2013-09-19 |
| Date Added to Maude | 2014-01-16 |
| 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 | SHERRY LAING |
| 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 | C2 NERVEMONITOR |
| Product Code | PDQ |
| Date Received | 2013-10-16 |
| Returned To Mfg | 2013-10-10 |
| Catalog Number | 05.662.001 |
| Lot Number | 10M007 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| 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 | 2013-10-16 |