FDA Adverse Event
Injury
Summary report: N
UNKNOWN IMPLANT
MDR report key: 12556440
·
Received September 30, 2021
Report
- Report Number
- 2027971-2021-115422
- Event Type
- Injury
- Date Received
- September 30, 2021
- Date of Event
- July 27, 2021
- Report Date
- September 30, 2021
- Manufacturer
- NOBEL BIOCARE AB
- Product Code
- DZE
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- SP
- Reporter Occupation
- DENTIST
Narratives
Description of Event or Problem · 1
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE. (B)(4).USER:(B)(4) RECEIVED DATE OF THE RETURN PRODUCT:30/09/2021.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1451452 | UNKNOWN IMPLANT | ENDOSSEOUS DENTAL IMPLANT | DZE | NOBEL BIOCARE AB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |