MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-13 for STRYKER 5407-120-970C manufactured by Stryker.
[89616365]
Patient undergoing laminectomy when the drill attachment unexpectedly became hot and caused a burn to the skin adjacent to the lumbar incision.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5072752 |
| MDR Report Key | 6950923 |
| Date Received | 2017-10-13 |
| Date of Report | 2017-10-11 |
| Date of Event | 2017-10-06 |
| Date Added to Maude | 2017-10-16 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | STRYKER |
| Generic Name | DRILLS, BURRS, TREPHINES AND ACCESSORIES |
| Product Code | HBG |
| Date Received | 2017-10-13 |
| Returned To Mfg | 2017-10-11 |
| Model Number | 5407-120-970C |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER |
| Manufacturer Address | US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-10-13 |