CM DRIVE ACQUA IMPLANT 4.3X16
Report
- Report Number
- 3008261720-2019-01648
- Event Type
- Injury
- Date Received
- April 22, 2019
- Date of Event
- April 3, 2019
- Report Date
- July 8, 2019
- Manufacturer
- NEODENT - JJGC S.A.
- Product Code
- DZE
- UDI-DI
- 07899878016540
- PMA / PMN Number
- K133592
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- DENTIST
Narratives
ADDITIONAL PATIENT CODES (F10): 1994/PAIN; 1888/BLEEDING. 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.
ADDITIONAL PATIENT CODES (F10): 1994/PAIN; 1888/BLEEDING. 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.
ADDITIONAL PATIENT CODES (F10): 1994/PAIN; 2104/TISSUE DAMAGE. EXEMPTION NUMBER: E2015015. INSTRADENT USA, INC IS SUBMITTING THE REPORT ON BEHALF OF NEODENT - JJGC.
THE CLINICIAN REPORTED THAT OVER 2 MONTHS AFTER THE DENTAL IMPLANT WAS PLACED IN ADA SITE 6 IN THE PATIENT'S MOUTH, THE IMPLANT DID NOT INTEGRATE IN TYPE III BONE. THE CLINICIAN NOTED AN INFECTION, PAIN, BLEEDING, IMPLANT MOBILITY AND HYPERSENSITIVITY IN THIS PATIENT WITH FAIR HYGIENE. 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 OVER 2 MONTHS AFTER THE DENTAL IMPLANT WAS PLACED IN ADA SITE 6 IN THE PATIENT'S MOUTH, THE IMPLANT DID NOT INTEGRATE IN TYPE III BONE. THE CLINICIAN NOTED AN INFECTION, PAIN, BLEEDING, IMPLANT MOBILITY AND HYPERSENSITIVITY IN THIS PATIENT WITH FAIR HYGIENE. 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 OVER 2 MONTHS AFTER THE DENTAL IMPLANT WAS PLACED IN ADA SITE 6 IN THE PATIENT'S MOUTH, THE IMPLANT DID NOT INTEGRATE IN TYPE III BONE. THE CLINICIAN NOTED AN INFECTION, PAIN, BLEEDING, IMPLANT MOBILITY AND HYPERSENSITIVITY IN THIS PATIENT WITH FAIR HYGIENE. 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 |
|---|---|---|---|---|---|---|---|
| 329096 | CM DRIVE ACQUA IMPLANT 4.3X16 | ENDOSSEOUS DENTAL IMPLANT | DZE | NEODENT - JJGC S.A. | 133222 | 07899878016540 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 37 YR | Required Intervention | BONE GRAFT| BONE GRAFT| BONE GRAFT| BONE GRAFT |