FDA Adverse Event
Death
Summary report: N
NOBELREPLACE CC PMC NP 3.5X10MM
MDR report key: 10912084
·
Received November 26, 2020
Report
- Report Number
- 2027971-2020-54294
- Event Type
- Death
- Date Received
- November 26, 2020
- Date of Event
- August 27, 2020
- Report Date
- November 26, 2020
- Manufacturer
- NOBEL BIOCARE AB
- Product Code
- DZE
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- HU
- Reporter Occupation
- DENTIST
Narratives
Description of Event or Problem · 1
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Description of Event or Problem · 1
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1373122 | NOBELREPLACE CC PMC NP 3.5X10MM | ENDOSSEOUS DENTAL IMPLANT | DZE | NOBEL BIOCARE AB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Death| R |