GM HELIX IMPLANT 4.3X13
Report
- Report Number
- 3008261720-2018-02730
- Event Type
- Injury
- Date Received
- June 22, 2018
- Date of Event
- March 29, 2018
- Report Date
- June 22, 2018
- Manufacturer
- NEODENT - JJGC S.A.
- Product Code
- DZE
- UDI-DI
- 07899878024224
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- DENTIST
Narratives
EXEMPTION NUMBER: E2015015. INSTRADENT USA, INC IS SUBMITTING THE REPORT ON BEHALF OF NEODENT - JJGC. THE PREMARKET ID IS K163194. THIS NUMBER CORRESPOND TO A NEW DEVICE, WHICH HAS NOT BEEN UPDATED IN THE SOFTWARE SYSTEM USED TO SEND THE REPORT TO FDA, BECAUSE OF THAT THE G5 FIELD IS EMPTY. IN ADDITION, WE ARE ALREADY WORKING ON THE UPDATE OF THIS CODE ON THE SOFTWARE SYSTEM OF THE COMPANY.
EXEMPTION NUMBER: E2015015. INSTRADENT USA, INC IS SUBMITTING THE REPORT ON BEHALF OF NEODENT - JJGC. THE PREMARKET ID IS K163194. THIS NUMBER CORRESPOND TO A NEW DEVICE, WHICH HAS NOT BEEN UPDATED IN THE SOFTWARE SYSTEM USED TO SEND THE REPORT TO FDA, BECAUSE OF THAT THE G5 FIELD IS EMPTY. IN ADDITION, WE ARE ALREADY WORKING ON THE UPDATE OF THIS CODE ON THE SOFTWARE SYSTEM OF THE COMPANY.
(B)(4). THE DENTIST REPORTED THAT 2 MONTHS AFTER DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION 20#, ITS NON-OSSEOINTEGRATION WAS OBSERVED. IN ADDITION, THE PATIENT PRESENTED INSUFFICIENT BONE QUALITY/QUANTITY (BONE TYPE II).
(B)(4). THE DENTIST REPORTED THAT 2 MONTHS AFTER DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION 20#, ITS NON-OSSEOINTEGRATION WAS OBSERVED. IN ADDITION, THE PATIENT PRESENTED INSUFFICIENT BONE QUALITY/QUANTITY (BONE TYPE II).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 473225 | GM HELIX IMPLANT 4.3X13 | ENDOSSEOUS DENTAL IMPLANT | DZE | NEODENT - JJGC S.A. | 800325533 | 07899878024224 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |