FDA Adverse Event
Injury
Summary report: N
CM DRIVE IMPLANT, TITANIUM, 4.3X11.5 MM
MDR report key: 7029999
·
Received November 14, 2017
Report
- Report Number
- 3008261720-2017-05197
- Event Type
- Injury
- Date Received
- November 14, 2017
- Date of Event
- May 3, 2017
- Report Date
- November 14, 2017
- Manufacturer
- NEODENT - JJGC S.A.
- Product Code
- DZE
- UDI-DI
- 07899878023302
- PMA / PMN Number
- K123022
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- DENTIST
Narratives
Additional Manufacturer Narrative · 0
EXEMPTION NUMBER: E2015015. INSTRADENT USA, INC IS SUBMITTING THE REPORT ON BEHALF OF NEODENT - JJGC.
Additional Manufacturer Narrative · 0
EXEMPTION NUMBER: E2015015. INSTRADENT USA, INC IS SUBMITTING THE REPORT ON BEHALF OF NEODENT - JJGC.
Description of Event or Problem · 0
THE CLINICIAN REPORTED THAT THE DENTAL IMPLANT FAILED. THE DEVICE WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION.
Description of Event or Problem · 0
(B)(4). THE CLINICIAN REPORTED THAT THE DENTAL IMPLANT FAILED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 807145 | CM DRIVE IMPLANT, TITANIUM, 4.3X11.5 MM | ENDOSSEOUS DENTAL IMPLANT | DZE | NEODENT - JJGC S.A. | 07899878023302 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |