CM DRIVE ACQUA IMPL TI 4.3X13
Report
- Report Number
- 3008261720-2018-02779
- Event Type
- Malfunction
- Date Received
- June 28, 2018
- Date of Event
- May 21, 2018
- Report Date
- July 10, 2018
- Manufacturer
- NEODENT JJGC S.A.
- Product Code
- DZE
- UDI-DI
- 07899878016533
- PMA / PMN Number
- K133592
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- DENTIST
Narratives
ON 07/02/2018, WE RECEIVED ADDITIONAL INFORMATION INDICATING THAT ANOTHER IMPLANT WAS PLACED IN THE SAME SITE ON THE SAME DAY (SAME DAY REMOVAL). NO MEDICAL INTERVENTION WAS NEEDED. 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 ON THE DAY THE IMMEDIATE IMPLANT WAS PLACED IN ADA SITE 4 IN THE MOUTH, THE IMPLANT FAILED TO INTEGRATE. THE PATIENT WAS REPORTED TO HAVE TYPE 2 BONE QUALITY. THE SITE WAS NOT GRAFTED. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED COMPLICATIONS.
THE CLINICIAN REPORTED THAT ON THE DAY THE IMMEDIATE IMPLANT WAS PLACED IN ADA SITE 4 IN THE MOUTH, THE IMPLANT FAILED TO INTEGRATE. THE PATIENT WAS REPORTED TO HAVE TYPE 2 BONE QUALITY. THE SITE WAS NOT GRAFTED. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED COMPLICATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 490213 | CM DRIVE ACQUA IMPL TI 4.3X13 | ENDOSSEOUS DENTAL IMPLANT | DZE | NEODENT JJGC S.A. | 126861I | 07899878016533 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Required Intervention |