CM DRIVE IMPLANT, TITANIUM, 4.3X13 MM
Report
- Report Number
- 3008261720-2017-06696
- Event Type
- Injury
- Date Received
- December 8, 2017
- Date of Event
- May 24, 2017
- Report Date
- April 11, 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
- TX, 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
EXEMPTION NUMBER: E2015015. INSTRADENT USA, INC IS SUBMITTING THE REPORT ON BEHALF OF NEODENT - JJGC.
THE CLINICIAN REPORTED THAT THERE IS A BROKEN PIECE IN THE IMPLANT. THE IMPLANT WAS PLACED AND REMOVED ON THE SAME DAY. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED POST-OPERATIVE COMPLICATIONS. (B)(4).
THE CLINICIAN REPORTED THAT THERE IS A BROKEN PIECE IN THE IMPLANT. THE IMPLANT WAS PLACED AND REMOVED ON THE SAME DAY. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED POST-OPERATIVE COMPLICATIONS.
THE CLINICIAN REPORTED THAT THERE IS A BROKEN PIECE IN THE IMPLANT. THE IMPLANT WAS PLACED AND REMOVED ON THE SAME DAY. 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 |
|---|---|---|---|---|---|---|---|
| 879329 | CM DRIVE IMPLANT, TITANIUM, 4.3X13 MM | ENDOSSEOUS DENTAL IMPLANT | DZE | NEODENT - JJGC S.A. | 85207I | 07899878023319 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |