MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-05-29 for MANDIBULAR OSTEOTOMY BLADE THIN CE 0197 * manufactured by Stryker Instruments.
[870750]
The osteotomy blade (thin) was being used by the surgeon within the patient's mouth. While blade on dental drill, blade broke. It was retrieved from patient's mouth. No harm to patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1057510 |
| MDR Report Key | 1057510 |
| Date Received | 2008-05-29 |
| Date of Report | 2008-05-29 |
| Date of Event | 2008-05-28 |
| Report Date | 2008-05-29 |
| Date Reported to FDA | 2008-05-29 |
| Date Added to Maude | 2008-06-10 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MANDIBULAR OSTEOTOMY BLADE THIN |
| Generic Name | BLADE, OSTEOTOMY |
| Product Code | DZH |
| Date Received | 2008-05-29 |
| Model Number | CE 0197 |
| Catalog Number | * |
| Lot Number | 31206010717101712 |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 1025044 |
| Manufacturer | STRYKER INSTRUMENTS |
| Manufacturer Address | 4100 EAST MILHAM AVE. KALAMAZOO MI 49001 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-05-29 |