FDA Adverse Event
Injury
Summary report: N
SOLO DIAMOND
MDR report key: 18806367
·
Received February 29, 2024
Report
- Report Number
- 2511556-2024-00001
- Event Type
- Injury
- Date Received
- February 29, 2024
- Date of Event
- February 12, 2024
- Report Date
- February 15, 2024
- Manufacturer
- PREMIER DENTAL PRODUCTS COMPANY
- Product Code
- DZP
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- DENTIST
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
THE DIAMOND BUR WAS BENT WHILE WORKING ON A PATIENT'S TOOTH. PATIENT WILL NEED CROWN AND A ROOT CANAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 445572 | SOLO DIAMOND | DIAMOND, DENTAL BURR | DZP | PREMIER DENTAL PRODUCTS COMPANY | M0115551 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |