CM TITAMAX EX ACQUA IMPL TI 4.0X13
Report
- Report Number
- 3008261720-2018-00970
- Event Type
- Injury
- Date Received
- March 2, 2018
- Date of Event
- January 12, 2017
- Report Date
- March 2, 2018
- Manufacturer
- NEODENT - JJGC S.A.
- Product Code
- DZE
- UDI-DI
- 07899878016571
- PMA / PMN Number
- K133592
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- DENTAL ASSISTANT
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 CLINICIAN REPORTED THAT, 3-4 MONTHS AFTER PLACEMENT IN SITE 10, THE IMPLANT WAS REMOVED DUE TO BONE RESORPTION AND MOBILITY. IT IS NOTED THAT PRIMARY STABILITY WAS ACHIEVED BUT OSSEOINTEGRATION WAS NOT. IT IS ALSO REPORTED THAT THERE WAS EVIDENCE OF DEHISCENCE. BONE QUALITY WAS DETERMINED TO BE TYPE III. THE DEVICE WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. NO PATIENT COMPLICATIONS WERE REPORTED.
THE CLINICIAN REPORTED THAT, 3-4 MONTHS AFTER PLACEMENT IN SITE 10, THE IMPLANT WAS REMOVED DUE TO BONE RESORPTION AND MOBILITY. IT IS NOTED THAT PRIMARY STABILITY WAS ACHIEVED BUT OSSEOINTEGRATION WAS NOT. IT IS ALSO REPORTED THAT THERE WAS EVIDENCE OF DEHISCENCE. BONE QUALITY WAS DETERMINED TO BE TYPE III. THE DEVICE WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. NO PATIENT COMPLICATIONS WERE REPORTED. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 152518 | CM TITAMAX EX ACQUA IMPL TI 4.0X13 | ENDOSSEOUS DENTAL IMPLANT | DZE | NEODENT - JJGC S.A. | 18378 | 07899878016571 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Required Intervention |