FDA Adverse Event
Injury
Summary report: N
2027971-2022-051066
MDR report key: 13775014
·
Received March 15, 2022
Report
- Report Number
- 2027971-2022-051066
- Event Type
- Injury
- Date Received
- March 15, 2022
- Date of Event
- March 3, 2022
- Report Date
- March 15, 2022
- Manufacturer
- NOBEL BIOCARE USA, LLC
- Product Code
- DZE
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- SP
- 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 |
|---|---|---|---|---|---|---|---|
| 1292467 | DZE | NOBEL BIOCARE USA, LLC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Female | Required Intervention |