FDA Adverse Event
Injury
Summary report: N
NOBELACTIVE INTERNAL NP 3.5X11.5MM
MDR report key: 11889768
·
Received May 26, 2021
Report
- Report Number
- 2027971-2021-74780
- Event Type
- Injury
- Date Received
- May 26, 2021
- Date of Event
- March 29, 2021
- Manufacturer
- NOBEL BIOCARE USA INC
- Product Code
- DZE
- UDI-DI
- 7332747010596
- PMA / PMN Number
- K071370
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- DENTIST
Narratives
Description of Event or Problem · 1
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 782426 | NOBELACTIVE INTERNAL NP 3.5X11.5MM | ENDOSSEOUS DENTAL IMPLANT | DZE | NOBEL BIOCARE USA INC | 13070462 | 7332747010596 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Required Intervention |