CM ALVIM IMPLANT 3.5X10
Report
- Report Number
- 3008261720-2018-04497
- Event Type
- Injury
- Date Received
- September 7, 2018
- Date of Event
- August 6, 2018
- Report Date
- September 7, 2018
- Manufacturer
- NEODENT - JJGC S.A.
- Product Code
- DZE
- UDI-DI
- 07898237569055
- PMA / PMN Number
- K101945
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- DENTIST
Narratives
EXEMPTION NUMBER: E2015015. INSTRADENT USA, INC IS SUBMITTING THE REPORT ON BEHALF OF NEODENT - JJGC.
EXEMPTION NUMBER: E2015015. INSTRADENT USA, INC IS SUBMITTING THE REPORT ON BEHALF OF NEODENT - JJGC.
THE CLINICIAN REPORTED THAT 7.5 MONTHS AFTER THE DENTAL IMPLANT WAS PLACED IN ADA SITE 10 IN THE MOUTH, THE IMPLANT HAD NOT ACHIEVED INTEGRATION. THE IMPLANT WAS STILL NOT INTEGRATED AT TIME OF ABUTMENT PLACEMENT. CLINICIAN REPORTS AN INFECTION AND A FISTULA. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED POST-OPERATIVE COMPLICATIONS.
THE CLINICIAN REPORTED THAT 7.5 MONTHS AFTER THE DENTAL IMPLANT WAS PLACED IN ADA SITE 10 IN THE MOUTH, THE IMPLANT HAD NOT ACHIEVED INTEGRATION. THE IMPLANT WAS STILL NOT INTEGRATED AT TIME OF ABUTMENT PLACEMENT. CLINICIAN REPORTS AN INFECTION AND A FISTULA. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED POST-OPERATIVE COMPLICATIONS. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 697108 | CM ALVIM IMPLANT 3.5X10 | ENDOSSEOUS DENTAL IMPLANT | DZE | NEODENT - JJGC S.A. | 121285 | 07898237569055 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Required Intervention | ABUTMENT PLACEMENT| ABUTMENT PLACEMENT| ABUTMENT PLACEMENT |