FDA Adverse Event
Injury
Summary report: N
NOBELPARALLEL CC NP 3.75X8.5MM
MDR report key: 10870633
·
Received November 19, 2020
Report
- Report Number
- 2027971-2020-52004
- Event Type
- Injury
- Date Received
- November 19, 2020
- Date of Event
- November 9, 2020
- Report Date
- November 19, 2020
- Manufacturer
- NOBEL BIOCARE AB
- Product Code
- DZE
- UDI-DI
- 7332747091434
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- SP
- Reporter Occupation
- DENTIST
Narratives
Description of Event or Problem · 0
IMPLANT FAILED DUE TO LOSS OF OSSEOINTEGRATE. 24.11.2020 17:52:32 CET S. (B)(6). USER: (B)(6) RECEIVED DATE OF THE RETURN PRODUCT:17/11/2020.
Description of Event or Problem · 1
IMPLANT FAILED DUE TO LOSS OF OSSEOINTEGRATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1332403 | NOBELPARALLEL CC NP 3.75X8.5MM | ENDOSSEOUS DENTAL IMPLANT | DZE | NOBEL BIOCARE AB | 12043539 | 7332747091434 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Life Threatening| R |