GM HELIX IMPLANT 6.0X10
Report
- Report Number
- 3008261720-2019-00936
- Event Type
- Injury
- Date Received
- March 2, 2019
- Date of Event
- February 8, 2019
- Report Date
- July 5, 2019
- Manufacturer
- NEODENT - JJGC S.A.
- Product Code
- DZE
- UDI-DI
- 07899878028727
- PMA / PMN Number
- K180536
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- DENTIST
Narratives
PREMARKET ID: K180536. EXEMPTION NUMBER: E2015015. (B)(4). THE INFORMATION PROVIDED IN THIS REPORT WAS BASED ON INFORMATION GIVEN BY THE DENTIST IN NEODENT¿S PRODUCTS WARRANTY FORM THAT WAS RECORDED IN THE SYSTEM THAT IS USED BY BOTH THE MANUFACTURER AND THE SUBSIDIARY. THE ORIGINAL COMPLAINT AND THE PRODUCT WERE RECEIVED BY THE SUBSIDIARY AND DID NOT ARRIVE IN THE MANUFACTURER YET. WHEN THIS HAPPENS, A NEW EVALUATION OF THE COMPLAINT WILL BE CARRIED OUT AND, IF NECESSARY, A NEW FOLLOW-UP REPORT WILL BE SEND.
SECTION G5: PREMARKET ID: K180536. FOLLOW-UP IS BEING SENT TO INCLUDE CODE 4310 IN FIELD H6 THE COMPLAINT WAS RECEIVED BY MANUFACTURER AND, AFTER ANALYSIS, NEW INFORMATIONS WERE OBTAINED. A FOLLOW-UP IS BEING SENT TO CORRECT THESE INFORMATIONS ACCORDING TO THE EVALUATION MADE. THE INVESTIGATION OF THE COMPLAINT WAS CARRIED OUT CONSIDERING THE ANALYSIS OF THE INFORMATION GIVEN BY THE DENTIST IN THE GUARANTEE FORM, VISUAL CONFERENCE OF THE PRODUCT RETURNED BY THE DENTIST AND THE EVALUATION OF RELEVANT PRODUCTION RECORDS.
SECTION G5: PREMARKET ID: K180536. EXEMPTION NUMBER: E2015015. INSTRADENT USA, INC IS SUBMITTING THE REPORT ON BEHALF OF NEODENT - JJGC.
THE CLINICIAN REPORTED OVER 2 MONTHS AFTER THE DENTAL IMPLANT AND HEALING CAP WERE PLACED IN ADA SITE 18 IN THE MOUTH, THE IMPLANT DID NOT ACHIEVE OSSEOINTEGRATION IN TYPE III BONE. CLINICIAN NOTED THE PATIENT'S MOBILITY, INFLAMMATION AND SYSTEMIC ISSUES. THE SITE WAS GRAFTED. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED POST-OPERATIVE COMPLICATIONS.
THE CLINICIAN REPORTED OVER 2 MONTHS AFTER THE DENTAL IMPLANT AND HEALING CAP WERE PLACED IN ADA SITE 18 IN THE MOUTH, THE IMPLANT DID NOT ACHIEVE OSSEOINTEGRATION IN TYPE III BONE. CLINICIAN NOTED THE PATIENT'S MOBILITY, INFLAMMATION AND SYSTEMIC ISSUES. THE SITE WAS GRAFTED. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED POST-OPERATIVE COMPLICATIONS.
THE CLINICIAN REPORTED OVER 2 MONTHS AFTER THE DENTAL IMPLANT AND HEALING CAP WERE PLACED IN ADA SITE 18 IN THE MOUTH, THE IMPLANT DID NOT ACHIEVE OSSEOINTEGRATION IN TYPE III BONE. CLINICIAN NOTED THE PATIENT'S MOBILITY, INFLAMMATION AND SYSTEMIC ISSUES. THE SITE WAS GRAFTED. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED POST-OPERATIVE COMPLICATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 177804 | GM HELIX IMPLANT 6.0X10 | ENDOSSEOUS DENTAL IMPLANT | DZE | NEODENT - JJGC S.A. | 800337510 | 07899878028727 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Required Intervention | BONE GRAFT| BONE GRAFT| BONE GRAFT| BONE GRAFT |