CM DRIVE IMPLANT, TITANIUM, 4.3X8 MM
Report
- Report Number
- 3008261720-2018-03978
- Event Type
- Injury
- Date Received
- August 29, 2018
- Date of Event
- January 22, 2018
- Report Date
- August 29, 2018
- Manufacturer
- NEODENT - JJGC S.A.
- Product Code
- DZE
- UDI-DI
- 07899878023401
- PMA / PMN Number
- K123022
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, 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. CONSIDERING THE SURGICAL METHODOLOGY, IT WAS SEEN THAT THE DENTIST HAS SELECTED AN IMPLANT DESIGN WHICH IS NOT RECOMMENDED FOR THE PATIENT'S BONE QUALITY.
THE CLINICIAN REPORTS 7 MONTHS AFTER THE DENTAL IMPLANT AND ABUTMENT WERE PLACED IN ADA SITE 30 IN THE MOUTH, THE IMPLANT HAD NOT INTEGRATED IN TYPE II BONE. CLINICIAN REPORTS MOBILITY. THE SITE WAS GRAFTED. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED COMPLICATIONS.
THE CLINICIAN REPORTS 7 MONTHS AFTER THE DENTAL IMPLANT AND ABUTMENT WERE PLACED IN ADA SITE 30 IN THE MOUTH, THE IMPLANT HAD NOT INTEGRATED IN TYPE II BONE. CLINICIAN REPORTS MOBILITY. THE SITE WAS GRAFTED. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED COMPLICATIONS. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 670222 | CM DRIVE IMPLANT, TITANIUM, 4.3X8 MM | ENDOSSEOUS DENTAL IMPLANT | DZE | NEODENT - JJGC S.A. | 85200I | 07899878023401 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Required Intervention | GRAFT| GRAFT |