FDA Adverse Event
Death
Summary report: N
REPLACE SELECT TAPERED PMC RP 4.3X10MM
MDR report key: 10630724
·
Received October 5, 2020
Report
- Report Number
- 2027971-2020-40105
- Event Type
- Death
- Date Received
- October 5, 2020
- Date of Event
- August 24, 2020
- Report Date
- October 5, 2020
- Manufacturer
- NOBEL BIOCARE AB
- Product Code
- DZE
- UDI-DI
- 7332747073430
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- UK
- Reporter Occupation
- DENTIST
Narratives
Description of Event or Problem · 1
IMPLANT FAILED DUE TO FAILURE OF OSSEOINTEGRATION.
Description of Event or Problem · 1
IMPLANT FAILED DUE TO FAILURE OF OSSEOINTEGRATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1091701 | REPLACE SELECT TAPERED PMC RP 4.3X10MM | ENDOSSEOUS DENTAL IMPLANT | DZE | NOBEL BIOCARE AB | 12112843 | 7332747073430 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 30 YR | Death| R |