FDA Adverse Event
Injury
Summary report: N
9611993-2022-060249
MDR report key: 14321543
·
Received May 7, 2022
Report
- Report Number
- 9611993-2022-060249
- Event Type
- Injury
- Date Received
- May 7, 2022
- Date of Event
- March 4, 2021
- Manufacturer
- NOBEL BIOCARE (PRODUCTION) AB
- Product Code
- DZE
- PMA / PMN Number
- K050258
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AU
- Reporter Occupation
- DENTIST
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1632811 | DZE | NOBEL BIOCARE (PRODUCTION) AB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Male | Required Intervention |