CM DRIVE IMPLANT 4.3X13
Report
- Report Number
- 3008261720-2018-05142
- Event Type
- Injury
- Date Received
- October 24, 2018
- Date of Event
- October 3, 2018
- Report Date
- October 24, 2018
- Manufacturer
- NEODENT - JJGC S.A.
- Product Code
- DZE
- UDI-DI
- 07899878023319
- PMA / PMN Number
- K123022
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, 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 THAT 4.5 MONTHS AFTER THE DENTAL IMPLANT WAS PLACED IN ADA SITE 6 IN THE MOUTH, THE IMPLANT DID NOT INTEGRATE IN TYPE II BONE. CLINICIAN REPORTED A PREVIOUS AUGMENTATION IN THIS SITE. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED PATIENT COMPLICATIONS.
THE CLINICIAN REPORTED THAT 4.5 MONTHS AFTER THE DENTAL IMPLANT WAS PLACED IN ADA SITE 6 IN THE MOUTH, THE IMPLANT DID NOT INTEGRATE IN TYPE II BONE. CLINICIAN REPORTED A PREVIOUS AUGMENTATION IN THIS SITE. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED PATIENT COMPLICATIONS. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 841314 | CM DRIVE IMPLANT 4.3X13 | ENDOSSEOUS DENTAL IMPLANT | DZE | NEODENT - JJGC S.A. | 800326694I | 07899878023319 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Required Intervention |