FDA Adverse Event
Death
Summary report: N
NOBELACTIVE INTERNAL RP 4.3X8.5MM
MDR report key: 14937784
·
Received July 6, 2022
Report
- Report Number
- 2027971-2022-087560
- Event Type
- Death
- Date Received
- July 6, 2022
- Date of Event
- June 1, 2022
- Report Date
- July 6, 2022
- Manufacturer
- NOBEL BIOCARE AB
- Product Code
- DZE
- UDI-DI
- 07332747160277
- Product Problem
- 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 AN OSSEOINTEGRATION PROBLEM.
Description of Event or Problem · 0
IMPLANT FAILED DUE TO AN OSSEOINTEGRATION PROBLEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2765496 | NOBELACTIVE INTERNAL RP 4.3X8.5MM | ENDOSSEOUS DENTAL IMPLANT | DZE | NOBEL BIOCARE AB | 35223 | 12164739 | 07332747160277 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Male | Death| R |