FDA Adverse Event
Injury
Summary report: N
9611993-2023-041219
MDR report key: 16374930
·
Received February 14, 2023
Report
- Report Number
- 9611993-2023-041219
- Event Type
- Injury
- Date Received
- February 14, 2023
- Date of Event
- January 13, 2023
- Manufacturer
- NOBEL BIOCARE (PRODUCTION) AB
- Product Code
- DZE
- PMA / PMN Number
- K071370
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- DENTIST
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 721486 | DZE | NOBEL BIOCARE (PRODUCTION) AB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR | Male | Required Intervention |