FDA Adverse Event
Injury
Summary report: N
NPR AB W-U PLATFORM CAMLOG K 5.0/6.0
MDR report key: 21430874
·
Received February 21, 2025
Report
- Report Number
- 9611993-2025-049525
- Event Type
- Injury
- Date Received
- February 21, 2025
- Manufacturer
- NOBEL BIOCARE AB GÖTEBORG
- Product Code
- DZE
- PMA / PMN Number
- ASKU
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TW
- Reporter Occupation
- DENTIST
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
LOSS OF OSSEOINTEGRATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1620321 | NPR AB W-U PLATFORM CAMLOG K 5.0/6.0 | ENDOSSEOUS DENTAL IMPLANT | DZE | NOBEL BIOCARE AB GÖTEBORG |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Male | Required Intervention |