FDA Adverse Event
Injury
Summary report: N
GM HELIX ACQUA IMPLANT 5.0X10 MM
MDR report key: 8921770
·
Received August 22, 2019
Report
- Report Number
- 3008261720-2019-04192
- Event Type
- Injury
- Date Received
- August 22, 2019
- Date of Event
- June 20, 2019
- Report Date
- August 22, 2019
- Manufacturer
- NEODENT - JJGC S.A.
- Product Code
- DZE
- UDI-DI
- 07899878024996
- PMA / PMN Number
- K163194
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- DENTIST
Narratives
Additional Manufacturer Narrative · 1
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 AND 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.
Description of Event or Problem · 1
(B)(4) - THE DENTIST REPORTED THAT 23 DAYS AFTER THE DENTAL IMPLANT WAS INSTALLED IN PATIENT¿S MOUTH, ITS NON-OSSEOINTEGRATION WAS OBSERVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 713091 | GM HELIX ACQUA IMPLANT 5.0X10 MM | ENDOSSEOUS DENTAL IMPLANT | DZE | NEODENT - JJGC S.A. | 800360149 | 07899878024996 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Required Intervention |