FDA Adverse Event
Injury
Summary report: N
NOBELACTIVE INTERNAL NP 3.5X8.5MM
MDR report key: 10510281
·
Received September 9, 2020
Report
- Report Number
- 2027971-2020-33627
- Event Type
- Injury
- Date Received
- September 9, 2020
- Date of Event
- September 1, 2020
- Report Date
- September 9, 2020
- Manufacturer
- NOBEL BIOCARE AB
- Product Code
- DZE
- UDI-DI
- 7332747017939
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- RU
- Reporter Occupation
- DENTIST
Narratives
Description of Event or Problem · 1
PMN K083205, LST D080128, PROD CODE 76DZE, DEV 9611993.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 971598 | NOBELACTIVE INTERNAL NP 3.5X8.5MM | ENDOSSEOUS DENTAL IMPLANT | DZE | NOBEL BIOCARE AB | 786276 | 7332747017939 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR | Required Intervention |