FDA Adverse Event
Malfunction
Summary report: N
SHANK # 2 FISHER BUR / SS WHITE CARBIDE BURS
MDR report key: 22299548
·
Received June 20, 2025
Report
- Report Number
- MW5171690
- Event Type
- Malfunction
- Date Received
- June 20, 2025
- Report Date
- June 5, 2025
- Manufacturer
- SS WHITE BURS LLC
- Product Code
- EJL
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- UNKNOWN
- Health Professional
- *
Narratives
Description of Event or Problem · 0
TIP OF BUR BROKE OFF IN A PATIENT'S MOUTH DURING THE DENTAL PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1457791 | SHANK # 2 FISHER BUR / SS WHITE CARBIDE BURS | BUR, DENTAL | EJL | SS WHITE BURS LLC | 30024 | LO4L |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |