FDA Adverse Event
Injury
Summary report: N
9611993-2025-052677
MDR report key: 21498199
·
Received February 28, 2025
Report
- Report Number
- 9611993-2025-052677
- Event Type
- Injury
- Date Received
- February 28, 2025
- Date of Event
- October 29, 2024
- Manufacturer
- NOBEL BIOCARE (PRODUCTION) AB
- Product Code
- DZE
- PMA / PMN Number
- K202344
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- DENTIST
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
FAILURE TO OSSEOINTEGRATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 586497 | DZE | NOBEL BIOCARE (PRODUCTION) AB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Male | Required Intervention |