CM DRIVE IMPLANT 5.0X8
Report
- Report Number
- 3008261720-2018-05443
- Event Type
- Injury
- Date Received
- November 12, 2018
- Date of Event
- October 29, 2018
- Report Date
- January 14, 2019
- Manufacturer
- NEODENT - JJGC S.A.
- Product Code
- DZE
- UDI-DI
- 07899878023418
- PMA / PMN Number
- K123022
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, 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 1.5 MONTHS AFTER THE DENTAL IMPLANT WAS PLACED IN ADA SITE 14 IN THE MOUTH, THE IMPLANT DID NOT INTEGRATE IN TYPE III BONE. CLINICIAN NOTED THAT PATIENT'S FAIR HYGIENE. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED PATIENT COMPLICATIONS. (B)(4).
THE CLINICIAN REPORTED THAT 1.5 MONTHS AFTER THE DENTAL IMPLANT WAS PLACED IN ADA SITE 14 IN THE MOUTH, THE IMPLANT DID NOT INTEGRATE IN TYPE III BONE. CLINICIAN NOTED THAT PATIENT'S FAIR HYGIENE. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED PATIENT COMPLICATIONS.
THE CLINICIAN REPORTED THAT 1.5 MONTHS AFTER THE DENTAL IMPLANT WAS PLACED IN ADA SITE 14 IN THE MOUTH, THE IMPLANT DID NOT INTEGRATE IN TYPE III BONE. CLINICIAN NOTED THAT PATIENT'S FAIR HYGIENE. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED PATIENT COMPLICATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 900215 | CM DRIVE IMPLANT 5.0X8 | ENDOSSEOUS DENTAL IMPLANT | DZE | NEODENT - JJGC S.A. | 800304569I | 07899878023418 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Required Intervention |