FDA Adverse Event
Injury
Summary report: N
9611993-2024-102527
MDR report key: 20089599
·
Received August 28, 2024
Report
- Report Number
- 9611993-2024-102527
- Event Type
- Injury
- Date Received
- August 28, 2024
- Date of Event
- October 18, 2023
- Manufacturer
- NOBEL BIOCARE (PRODUCTION) AB
- Product Code
- DZE
- PMA / PMN Number
- K073142
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- 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 |
|---|---|---|---|---|---|---|---|
| 190806 | DZE | NOBEL BIOCARE (PRODUCTION) AB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Male | Required Intervention |