CM ALVIM ACQUA IMPL TI 3.5X11.5
Report
- Report Number
- 3008261720-2018-03989
- Event Type
- Injury
- Date Received
- August 29, 2018
- Date of Event
- April 13, 2018
- Report Date
- August 29, 2018
- Manufacturer
- NEODENT - JJGC S.A.
- Product Code
- DZE
- UDI-DI
- 07899878016717
- PMA / PMN Number
- K150199
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, 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. CONSIDERING THE SURGICAL METHODOLOGY, IT WAS SEEN THAT THE DENTIST HAS SELECTED AN IMPLANT DESIGN WHICH IS NOT RECOMMENDED FOR THE PATIENT'S BONE QUALITY.
THE CLINICIAN REPORTED THAT 1 MONTH AFTER THE DENTAL IMPLANT WAS PLACED IN ADA SITE 22 IN THE MOUTH, THE IMPLANT HAD NOT INTEGRATED. CLINICIAN REPORTED BONE LOSS, A FISTULA, AN ABSCESS AND INFLAMMATION. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED POST-OPERATIVE COMPLICATIONS.
THE CLINICIAN REPORTED THAT 1 MONTH AFTER THE DENTAL IMPLANT WAS PLACED IN ADA SITE 22 IN THE MOUTH, THE IMPLANT HAD NOT INTEGRATED. CLINICIAN REPORTED BONE LOSS, A FISTULA, AN ABSCESS AND INFLAMMATION. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED POST-OPERATIVE COMPLICATIONS. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 670476 | CM ALVIM ACQUA IMPL TI 3.5X11.5 | ENDOSSEOUS DENTAL IMPLANT | DZE | NEODENT - JJGC S.A. | 800320899 | 07899878016717 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Required Intervention |