FDA Adverse Event
Injury
Summary report: N
CAMLOG SCREW LINE IMPLANT PROMOTE PLUS
MDR report key: 20787889
·
Received November 26, 2024
Report
- Report Number
- 9613866-2024-21239
- Event Type
- Injury
- Date Received
- November 26, 2024
- Date of Event
- October 1, 2024
- Report Date
- January 23, 2025
- Manufacturer
- ALTATEC GMBH
- Product Code
- DZE
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- DENTIST
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
CODING DOESN`T MAKE SENSE. THE PRODUCT IS IN EVALUATION. IT IS NOT POSSIBLE TO INDICATE CONCLUSIONS AT THIS STAGE (INITIAL REPORT) NEITHER CODE NA NOR NI IS WORKING IN THE CODING SECTION C AND D (H4-H6).
Additional Manufacturer Narrative · 0
CODING DOESN`T MAKE SENSE. THE PRODUCT IS IN EVALUATION. IT IS NOT POSSIBLE TO INDICATE CONCLUSIONS AT THIS STAGE (INITIAL REPORT). NEITHER CODE NA NOR NI IS WORKING IN THE CODING SECTION C AND D (H4-H6). RESULT OF EVALUATION. IMPLANT REGIO 15 FRACTURED. CONSTRUCTION WAS A SINGLE CROWN PLACED ON THE IMPLANT. PATIENT SUFFERED FROM PERIIMPLANTITIS FOLLOWING BONE LOSS AND IMPLANT INSTABILITY. MATERIAL ANALYSIS CONCLUDED NO MATERIAL DEFECTS. FRACTURE WAS CAUSED BY MECHANICAL OVERLOADING OF THE IMPLANT.
Description of Event or Problem · 0
IMPLANT FRACTURE.
Description of Event or Problem · 0
IMPLANT FRACTURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2435170 | CAMLOG SCREW LINE IMPLANT PROMOTE PLUS | CAMLOG SCREW LINE IMPLANT PROMOTE PLUS | DZE | ALTATEC GMBH | K1054.3811 | 0000079324 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 41 YR | Male | Required Intervention |