FDA Adverse Event
Injury
Summary report: N
2027971-2022-030494
MDR report key: 13231087
·
Received January 11, 2022
Report
- Report Number
- 2027971-2022-030494
- Event Type
- Injury
- Date Received
- January 11, 2022
- Date of Event
- January 7, 2022
- Report Date
- January 11, 2022
- Manufacturer
- NOBEL BIOCARE USA, LLC
- Product Code
- DZE
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- FR
- 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 |
|---|---|---|---|---|---|---|---|
| 941205 | DZE | NOBEL BIOCARE USA, LLC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | Male | Required Intervention |