GM HELIX ACQUA IMPLANT 4.3X8
Report
- Report Number
- 3008261720-2019-02574
- Event Type
- Injury
- Date Received
- June 8, 2019
- Date of Event
- April 30, 2019
- Report Date
- July 15, 2019
- Manufacturer
- NEODENT - JJGC S.A.
- Product Code
- DZE
- UDI-DI
- 07899878024934
- PMA / PMN Number
- K163194
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- DENTIST
Narratives
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.
EXEMPTION NUMBER: E2015015. INSTRADENT USA, INC IS SUBMITTING THE REPORT ON BEHALF OF NEODENT - JJGC. 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.
(B)(4).
THE CLINICIAN REPORTED THAT 11 DAYS AFTER THE DENTAL IMPLANT WAS PLACED IN ADA SITE 19 IN THE PATIENT'S MOUTH, THE IMPLANT DID NOT ACHIEVE OSSEOINTEGRATION. THE CLINICIAN NOTED THE PATIENT¿S IMPLANT MOBILITY AND EXCELLENT HYGIENE. THE SITE WAS GRAFTED. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED PATIENT COMPLICATIONS.
THE CLINICIAN REPORTED THAT 11 DAYS AFTER THE DENTAL IMPLANT WAS PLACED IN ADA SITE 19 IN THE PATIENT'S MOUTH, THE IMPLANT DID NOT ACHIEVE OSSEOINTEGRATION. THE CLINICIAN NOTED THE PATIENT¿S IMPLANT MOBILITY AND EXCELLENT HYGIENE. THE SITE WAS GRAFTED. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED PATIENT COMPLICATIONS.
THE CLINICIAN REPORTED THAT 11 DAYS AFTER THE DENTAL IMPLANT WAS PLACED IN ADA SITE 19 IN THE PATIENT'S MOUTH, THE IMPLANT DID NOT ACHIEVE OSSEOINTEGRATION. THE CLINICIAN NOTED THE PATIENT¿S IMPLANT MOBILITY AND EXCELLENT HYGIENE. THE SITE WAS GRAFTED. 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 |
|---|---|---|---|---|---|---|---|
| 474693 | GM HELIX ACQUA IMPLANT 4.3X8 | ENDOSSEOUS DENTAL IMPLANT | DZE | NEODENT - JJGC S.A. | 151044 | 07899878024934 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | Required Intervention | BONE GRAFT| BONE GRAFT| BONE GRAFT |