FDA Adverse Event
Injury
Summary report: N
CAMLOG SCREW LINE IMPLANT
MDR report key: 20783908
·
Received November 26, 2024
Report
- Report Number
- 9613866-2024-21227
- Event Type
- Injury
- Date Received
- November 26, 2024
- Date of Event
- November 4, 2024
- Report Date
- January 22, 2025
- Manufacturer
- ALTATEC GMBH
- Product Code
- DZE
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AU
- 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.
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. RESULT OF THE EVALUATION: IMPLANT REGIO 36 FRACTURED. CONSTRUCTION WAS A SINGLE CROWN PLACED ON THE IMPLANT. PATIENT SUFFERED FROM PERIIMPLANTITIS FOLLOWING BONE LOSS AND IMPLANT INSTABILITY. MATERIAL ANALYSIS CONCLUDED INHOMOGENOUS 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 |
|---|---|---|---|---|---|---|---|
| 2443852 | CAMLOG SCREW LINE IMPLANT | CAMLOG SCREW LINE IMPLANT | DZE | ALTATEC GMBH | K1044.3811 | 0000081061 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Male | Required Intervention |