FDA Adverse Event
Injury
Summary report: N
NOBELPARALLEL CC NP 3.75X13MM
MDR report key: 11439706
·
Received March 8, 2021
Report
- Report Number
- 9611993-2021-45203
- Event Type
- Injury
- Date Received
- March 8, 2021
- Date of Event
- December 2, 2020
- Manufacturer
- NOBEL BIOCARE AB
- Product Code
- DZE
- UDI-DI
- 7332747091465
- PMA / PMN Number
- K073142
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- DENTIST
Narratives
Description of Event or Problem · 1
PMN K073142, LST D109680, PROD CODE 76DZE, DEV 9611993.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 328872 | NOBELPARALLEL CC NP 3.75X13MM | ENDOSSEOUS DENTAL IMPLANT | DZE | NOBEL BIOCARE AB | 12141495 | 7332747091465 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Required Intervention |