FDA Adverse Event
Injury
Summary report: N
NOBELREPLACE CC PMC RP 4.3X10MM
MDR report key: 12002380
·
Received June 15, 2021
Report
- Report Number
- 2027971-2021-81094
- Event Type
- Injury
- Date Received
- June 15, 2021
- Date of Event
- May 26, 2021
- Manufacturer
- NOBEL BIOCARE USA INC
- Product Code
- DZE
- UDI-DI
- 7332747073584
- PMA / PMN Number
- K073142
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- DENTIST
Narratives
Description of Event or Problem · 1
PMN K073142, LST D109680, PROD CODE 76DZE, DEV 2027971.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 895144 | NOBELREPLACE CC PMC RP 4.3X10MM | ENDOSSEOUS DENTAL IMPLANT | DZE | NOBEL BIOCARE USA INC | 13107137 | 7332747073584 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Required Intervention |