CM ALVIM ACQUA IMPLANT 5.0X8
Report
- Report Number
- 3008261720-2019-02614
- Event Type
- Injury
- Date Received
- June 12, 2019
- Date of Event
- March 26, 2019
- Report Date
- June 17, 2019
- Manufacturer
- NEODENT - JJGC S.A.
- Product Code
- DZE
- PMA / PMN Number
- K150199
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- DENTIST
Narratives
EXEMPTION NUMBER: E2015015. INSTRADENT USA, INC IS SUBMITTING THE REPORT ON BEHALF OF NEODENT - JJGC.
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 GIVENBY 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.
THE MISSING ARTICLE NUMBER AND LOT (BATCH) NUMBER WERE REQUESTED FROM THE INITIAL REPORTER. A FOLLOW UP REPORT WILL BE SUBMITTED UPON RECEIPT OF THE INFORMATION. EXEMPTION NUMBER: E2015015. INSTRADENT USA, INC IS SUBMITTING THE REPORT ON BEHALF OF NEODENT - JJGC.
THE CLINICIAN REPORTED THAT ALMOST 6 MONTHS AFTER THE DENTAL IMPLANT WAS PLACED IN ADA SITE 3 IN THE PATIENT'S MOUTH, THE IMPLANT DID NOT ACHIEVE OSSEOINTEGRATION IN TYPE I BONE. THE CLINICIAN NOTED IMPLANT MOBILITY IN THIS PATIENT WITH 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 ALMOST 6 MONTHS AFTER THE DENTAL IMPLANT WAS PLACED IN ADA SITE 3 IN THE PATIENT'S MOUTH, THE IMPLANT DID NOT ACHIEVE OSSEOINTEGRATION IN TYPE I BONE. THE CLINICIAN NOTED IMPLANT MOBILITY IN THIS PATIENT WITH 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 ALMOST 6 MONTHS AFTER THE DENTAL IMPLANT WAS PLACED IN ADA SITE 3 IN THE PATIENT'S MOUTH, THE IMPLANT DID NOT ACHIEVE OSSEOINTEGRATION IN TYPE I BONE. THE CLINICIAN NOTED IMPLANT MOBILITY IN THIS PATIENT WITH 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 |
|---|---|---|---|---|---|---|---|
| 487654 | CM ALVIM ACQUA IMPLANT 5.0X8 | ENDOSSEOUS DENTAL IMPLANT | DZE | NEODENT - JJGC S.A. | 800323970 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Required Intervention | BONE GRAFT, PROSTHESIS PLACEMENT| BONE GRAFT, PROSTHESIS PLACEMENT| BONE GRAFT, PROSTHESIS PLACEMENT| BONE GRAFT, PROSTHESIS PLACEMENT |