FDA Adverse Event
Injury
Summary report: N
2027971-2022-042973
MDR report key: 13562616
·
Received February 18, 2022
Report
- Report Number
- 2027971-2022-042973
- Event Type
- Injury
- Date Received
- February 18, 2022
- Date of Event
- December 8, 2021
- Manufacturer
- NOBEL BIOCARE USA, LLC
- Product Code
- DZE
- PMA / PMN Number
- K073142
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- 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 |
|---|---|---|---|---|---|---|---|
| 5221 | DZE | NOBEL BIOCARE USA, LLC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Male | Required Intervention |