FDA Adverse Event
Malfunction
Summary report: N
CM DRIVE IMPLANT, TITANIUM, 4.3X13 MM
MDR report key: 7631554
·
Received June 22, 2018
Report
- Report Number
- 3008261720-2018-02743
- Event Type
- Malfunction
- Date Received
- June 22, 2018
- Date of Event
- April 16, 2018
- Report Date
- June 22, 2018
- Manufacturer
- NEODENT JJGC S.A.
- Product Code
- DZE
- UDI-DI
- 07899878023319
- PMA / PMN Number
- K123022
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, 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 AFTER 3.5 MONTHS AFTER THE DENTAL IMPLANT WAS PLACED IN ADA SITE 10 IN THE MOUTH, THE IMPLANT WAS REMOVED. TYPE III BONE WAS REPORTED. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED COMPLICATIONS.
Description of Event or Problem · 0
THE CLINICIAN REPORTED THAT AFTER 3.5 MONTHS AFTER THE DENTAL IMPLANT WAS PLACED IN ADA SITE 10 IN THE MOUTH, THE IMPLANT WAS REMOVED. TYPE III BONE WAS REPORTED. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED COMPLICATIONS. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 472943 | CM DRIVE IMPLANT, TITANIUM, 4.3X13 MM | ENDOSSEOUS DENTAL IMPLANT | DZE | NEODENT JJGC S.A. | 800326191I | 07899878023319 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR | Required Intervention |