FDA Adverse Event
Summary report: N
BRASSELER USA SURGICAL BUR
MDR report key: 8949904
·
Received August 29, 2019
Report
- Report Number
- MW5089475
- Date Received
- August 29, 2019
- Report Date
- August 28, 2019
- Manufacturer
- BRASSELER USA MEDICAL, LLC
- Product Code
- GFF
- Report Source
- Voluntary report
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
PHYSICIAN PERFORMING A MANDIBULAR OSTEOTOMY AND DURING THE PROCEDURE, A BURR BROKE. FDA SAFETY REPORT ID# (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 741920 | BRASSELER USA SURGICAL BUR | BUR, SURGICAL, GENERAL & PLASTIC SURGERY | GFF | BRASSELER USA MEDICAL, LLC | 04-C0302 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |