FDA Adverse Event
Injury
Summary report: N
NOBELPARALLEL CC RP 4.3X10MM
MDR report key: 11006850
·
Received December 15, 2020
Report
- Report Number
- 9611993-2020-55126
- Event Type
- Injury
- Date Received
- December 15, 2020
- Date of Event
- November 5, 2020
- Manufacturer
- NOBEL BIOCARE AB
- Product Code
- DZE
- UDI-DI
- 7332747091519
- PMA / PMN Number
- K073142
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- HU
- Reporter Occupation
- DENTIST
Narratives
Description of Event or Problem · 1
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE. (B)(6). USER: (B)(6) RECEIVED DATE OF THE RETURN PRODUCT: 14/12/2020.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1471395 | NOBELPARALLEL CC RP 4.3X10MM | ENDOSSEOUS DENTAL IMPLANT | DZE | NOBEL BIOCARE AB | 12121536 | 7332747091519 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Required Intervention |