FDA Adverse Event
Death
Summary report: N
NOBELREPLACE CC PMC RP 4.3X13MM
MDR report key: 10787549
·
Received November 4, 2020
Report
- Report Number
- 2027971-2020-47902
- Event Type
- Death
- Date Received
- November 4, 2020
- Date of Event
- October 28, 2020
- Report Date
- November 4, 2020
- Manufacturer
- NOBEL BIOCARE AB
- Product Code
- DZE
- UDI-DI
- 7332747073560
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- IT
- Reporter Occupation
- DENTIST
Narratives
Description of Event or Problem · 1
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1252186 | NOBELREPLACE CC PMC RP 4.3X13MM | ENDOSSEOUS DENTAL IMPLANT | DZE | NOBEL BIOCARE AB | 13037017 | 7332747073560 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Death| R |