FDA Adverse Event
Death
Summary report: N
NOBELPARALLEL CC RP 4.3X8.5MM
MDR report key: 15634283
·
Received October 19, 2022
Report
- Report Number
- 9611993-2022-103630
- Event Type
- Death
- Date Received
- October 19, 2022
- Date of Event
- July 7, 2022
- Manufacturer
- NOBEL BIOCARE AB
- Product Code
- DZE
- UDI-DI
- 07332747161267
- PMA / PMN Number
- K173418
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- DENTIST
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
IMPLANT FAILED DUE TO OSSEOINTEGRATION PROBLEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2047040 | NOBELPARALLEL CC RP 4.3X8.5MM | ENDOSSEOUS DENTAL IMPLANT | DZE | NOBEL BIOCARE AB | 37971 | 12170703 | 07332747161267 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | Male | Required Intervention |