FDA Adverse Event
Injury
Summary report: N
UNKNOWN ¿ IMPLANT
MDR report key: 18520653
·
Received January 16, 2024
Report
- Report Number
- 2027971-2024-033468
- Event Type
- Injury
- Date Received
- January 16, 2024
- Date of Event
- December 21, 2023
- Manufacturer
- NOBEL BIOCARE AB
- Product Code
- DZE
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- BE
- Reporter Occupation
- DENTIST
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
FAILURE OSSEOINTEGRATE. 16.01.2024 16:03:16 CET (5001035) IMPLANT FAILED DUE TO FAILURE OF OSSEOINTEGRATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1677490 | UNKNOWN ¿ IMPLANT | ENDOSSEOUS DENTAL IMPLANT | DZE | NOBEL BIOCARE AB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Male | Required Intervention |