FDA Adverse Event
Malfunction
Summary report: N
S-CLEAN ONEQ-SL FIXTURE
MDR report key: 20850327
·
Received December 4, 2024
Report
- Report Number
- 3013958319-2024-70001
- Event Type
- Malfunction
- Date Received
- December 4, 2024
- Date of Event
- January 10, 2024
- Manufacturer
- DENTIS CO.,LTD
- Product Code
- DZE
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
DENTAL IMPLANT FIXTURE FRACTURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2227900 | S-CLEAN ONEQ-SL FIXTURE | S-CLEAN ONEQ-SL FIXTURE | DZE | DENTIS CO.,LTD | DSSOFR4210 | 19D122 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Male |