CM DRIVE IMPL TI 4.3X8
Report
- Report Number
- 3008261720-2018-03929
- Event Type
- Injury
- Date Received
- August 29, 2018
- Date of Event
- June 12, 2018
- Report Date
- August 29, 2018
- Manufacturer
- NEODENT - JJGC S.A.
- Product Code
- DZE
- UDI-DI
- 07898237569277
- PMA / PMN Number
- K123022
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, 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 REPORTED 5 MONTHS AFTER THE DENTAL IMPLANT WAS PLACED IN ADA SITE 11 IN THE MOUTH, THE IMPLANT DID NOT ACHIEVE INTEGRATION IN TYPE I BONE. CLINICIAN REPORTS BONE LOSS, MOBILITY AND DEHISCENCE. THE SITE WAS GRAFTED. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED COMPLICATIONS.
THE CLINICIAN REPORTED 5 MONTHS AFTER THE DENTAL IMPLANT WAS PLACED IN ADA SITE 11 IN THE MOUTH, THE IMPLANT DID NOT ACHIEVE INTEGRATION IN TYPE I BONE. CLINICIAN REPORTS BONE LOSS, MOBILITY AND DEHISCENCE. 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 |
|---|---|---|---|---|---|---|---|
| 670207 | CM DRIVE IMPL TI 4.3X8 | ENDOSSEOUS DENTAL IMPLANT | DZE | NEODENT - JJGC S.A. | 46377I | 07898237569277 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Required Intervention | GRAFT| GRAFT |