CM DRIVE IMPL TI 3.5X10
Report
- Report Number
- 3008261720-2018-03333
- Event Type
- Injury
- Date Received
- August 29, 2018
- Date of Event
- March 26, 2018
- Report Date
- August 29, 2018
- Manufacturer
- NEODENT - JJGC S.A.
- Product Code
- DZE
- UDI-DI
- 07898237569208
- PMA / PMN Number
- K123022
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NV, 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 3 WEEKS AFTER THE DENTAL IMPLANT WAS PLACED IN ADA SITE 21 IN THE MOUTH, THE IMPLANT DID NOT ACHIEVE INTEGRATION IN TYPE II BONE. CLINICIAN REPORTS PAIN, MOBILITY, INFLAMMATION AND AN ABSCESS. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED POST-OPERATIVE COMPLICATIONS.
THE CLINICIAN REPORTED 3 WEEKS AFTER THE DENTAL IMPLANT WAS PLACED IN ADA SITE 21 IN THE MOUTH, THE IMPLANT DID NOT ACHIEVE INTEGRATION IN TYPE II BONE. CLINICIAN REPORTS PAIN, MOBILITY, INFLAMMATION AND AN ABSCESS. 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 |
|---|---|---|---|---|---|---|---|
| 667814 | CM DRIVE IMPL TI 3.5X10 | ENDOSSEOUS DENTAL IMPLANT | DZE | NEODENT - JJGC S.A. | 32654I | 07898237569208 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Required Intervention |