CM DRIVE ACQUA IMPL TI 4.3X11.5
Report
- Report Number
- 3008261720-2018-04453
- Event Type
- Injury
- Date Received
- September 5, 2018
- Date of Event
- July 27, 2018
- Report Date
- September 5, 2018
- Manufacturer
- NEODENT - JJGC S.A.
- Product Code
- DZE
- UDI-DI
- 07899878016526
- PMA / PMN Number
- K133592
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- DENTIST
Narratives
EXEMPTION NUMBER: E2015015. INSTRADENT USA, INC IS SUBMITTING THE REPORTON 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 3 MONTHS AFTER THE DENTAL IMPLANT WAS PLACED IN ADA SITE 11 IN THE MOUTH, THE IMPLANT HAD NOT INTEGRATED IN TYPE II BONE. CLINICIAN REPORTS THE IMPLANT TORQUED OUT WHEN ATTEMPTING TO PLACE AN ABUTMENT. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED PATIENT COMPLICATIONS.
THE CLINICIAN REPORTED THAT 3 MONTHS AFTER THE DENTAL IMPLANT WAS PLACED IN ADA SITE 11 IN THE MOUTH, THE IMPLANT HAD NOT INTEGRATED IN TYPE II BONE. CLINICIAN REPORTS THE IMPLANT TORQUED OUT WHEN ATTEMPTING TO PLACE AN ABUTMENT. 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 |
|---|---|---|---|---|---|---|---|
| 688098 | CM DRIVE ACQUA IMPL TI 4.3X11.5 | ENDOSSEOUS DENTAL IMPLANT | DZE | NEODENT - JJGC S.A. | 800193557I | 07899878016526 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Required Intervention | ABUTMENT PLACEMENT| ABUTMENT PLACEMENT |