GM DRIVE ACQUA IMPLANT 4.3X13
Report
- Report Number
- 3008261720-2018-04826
- Event Type
- Injury
- Date Received
- October 1, 2018
- Date of Event
- September 6, 2018
- Report Date
- October 1, 2018
- Manufacturer
- NEODENT - JJGC S.A.
- Product Code
- DZE
- UDI-DI
- 07899878025122
- PMA / PMN Number
- K163194
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
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 3.5 MONTHS AFTER THE DENTAL IMPLANT AND ABUTMENT WERE PLACED IN ADA SITE 20 IN THE MOUTH, THE IMPLANT LOST INTEGRATION IN TYPE II BONE. CLINICIAN NOTED PATIENT'S PAIN. THE SITE WAS GRAFTED. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED POST-OPERATIVE COMPLICATIONS.
THE CLINICIAN REPORTED THAT 3.5 MONTHS AFTER THE DENTAL IMPLANT AND ABUTMENT WERE PLACED IN ADA SITE 20 IN THE MOUTH, THE IMPLANT LOST INTEGRATION IN TYPE II BONE. CLINICIAN NOTED PATIENT'S PAIN. THE SITE WAS GRAFTED. 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 |
|---|---|---|---|---|---|---|---|
| 762783 | GM DRIVE ACQUA IMPLANT 4.3X13 | ENDOSSEOUS DENTAL IMPLANT | DZE | NEODENT - JJGC S.A. | 126098 | 07899878025122 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | ABUTMENT PLACEMENT, GRAFT, ALVEOPLASTY/EXTRACTION| ABUTMENT PLACEMENT, GRAFT, ALVEOPLASTY/EXTRACTION| ABUTMENT PLACEMENT, GRAFT, ALVEOPLASTY/EXTRACTION |