FDA Adverse Event
Injury
Summary report: N
ANGLED ABUTMENT WITH SHOULDER IN
MDR report key: 16103353
·
Received January 4, 2023
Report
- Report Number
- MW5114173
- Event Type
- Injury
- Date Received
- January 4, 2023
- Report Date
- December 31, 2022
- Manufacturer
- UNIQA DENTAL LTD
- Product Code
- DZE
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
ABUTMENTS USED THAT IS NOT FDA APPROVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 146232 | ANGLED ABUTMENT WITH SHOULDER IN | IMPLANT, ENDOSSEOUS, ROOT-FORM | DZE | UNIQA DENTAL LTD |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Prefer Not To Disclose | Other| C |