FDA Adverse Event
Injury
Summary report: N
NOBELREPLACE CC PMC RP 4.3X10MM
MDR report key: 19744817
·
Received July 15, 2024
Report
- Report Number
- 2027971-2024-101681
- Event Type
- Injury
- Date Received
- July 15, 2024
- Date of Event
- March 2, 2024
- Report Date
- July 15, 2024
- Manufacturer
- NOBEL BIOCARE AB
- Product Code
- DZE
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- CH
- Reporter Occupation
- DENTIST
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 738729 | NOBELREPLACE CC PMC RP 4.3X10MM | ENDOSSEOUS DENTAL IMPLANT | DZE | NOBEL BIOCARE AB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |