CM TITAMSX IMPL TI 4.0X13
Report
- Report Number
- 3008261720-2017-05375
- Event Type
- Injury
- Date Received
- November 14, 2017
- Date of Event
- March 13, 2017
- Report Date
- December 27, 2017
- Manufacturer
- NEODENT - JJGC S.A.
- Product Code
- DZE
- UDI-DI
- 07898237568720
- PMA / PMN Number
- K101207
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- DENTIST
Narratives
EXEMPTION NUMBER: E2015015. INSTRADENT USA, INC IS SUBMITTING THE REPORTON BEHALF OF NEODENT - JJGC.
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 REPORTS THAT THE IMPLANT WAS IN PLACE IN THE PATIENT'S MOUTH AT ADA SITE #4. THE IMPLANT WAS NOT COVERED WITH BONE. THE PATIENT PRESENTED WITH PAIN AND MOBILITY AT THE TIME OF IMPLANT FAILURE.
THE CLINICIAN REPORTS THAT THE IMPLANT WAS IN PLACE IN THE PATIENT'S MOUTH AT ADA SITE #4. THE IMPLANT WAS NOT COVERED WITH BONE. THE PATIENT PRESENTED WITH PAIN AND MOBILITY AT THE TIME OF IMPLANT FAILURE.
THE CLINICIAN REPORTS THAT THE IMPLANT WAS IN PLACE IN THE PATIENT'S MOUTH AT ADA SITE #4. THE IMPLANT WAS NOT COVERED WITH BONE. THE PATIENT PRESENTED WITH PAIN AND MOBILITY AT THE TIME OF IMPLANT FAILURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 809227 | CM TITAMSX IMPL TI 4.0X13 | ENDOSSEOUS DENTAL IMPLANT | DZE | NEODENT - JJGC S.A. | 17556 | 07898237568720 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Required Intervention |