MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-15 for STRYKER BUR manufactured by Stryker Instruments.
[62913752]
While performing surgery, a stryker saw blade and a stryker bur broke inside the pt's mouth.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5066784 |
| MDR Report Key | 6186254 |
| Date Received | 2016-12-15 |
| Date of Report | 2016-12-15 |
| Date of Event | 2016-11-30 |
| Date Added to Maude | 2016-12-19 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 BUR |
| Generic Name | STRYKER BUR |
| Product Code | HTT |
| Date Received | 2016-12-15 |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | STRYKER INSTRUMENTS |
| Manufacturer Address | KALAMAZOO MI 49001 US 49001 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-12-15 |