FDA Adverse Event
Injury
Summary report: N
CM DRIVE ACQUA IMPL TI 3.5X13
MDR report key: 7173122
·
Received January 8, 2018
Report
- Report Number
- 3008261720-2018-00104
- Event Type
- Injury
- Date Received
- January 8, 2018
- Date of Event
- December 11, 2017
- Report Date
- January 8, 2018
- Manufacturer
- NEODENT - JJGC S.A.
- Product Code
- DZE
- UDI-DI
- 07899878016847
- PMA / PMN Number
- K133592
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, 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 REPORTS THE IMPLANT PLACED IN ADA SITE 6 FAILED UPON INSERTION DUE TO INADEQUATE BONE DENSITY AND AIR POCKETS. CLINICIAN NOTED MOBILITY AND BONE LOSS. THE IMPLANT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED COMPLICATIONS.
Description of Event or Problem · 0
THE CLINICIAN REPORTS THE IMPLANT PLACED IN ADA SITE 6 FAILED UPON INSERTION DUE TO INADEQUATE BONE DENSITY AND AIR POCKETS. CLINICIAN NOTED MOBILITY AND BONE LOSS. THE IMPLANT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED COMPLICATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 15171 | CM DRIVE ACQUA IMPL TI 3.5X13 | ENDOSSEOUS DENTAL IMPLANT | DZE | NEODENT - JJGC S.A. | 800308820I | 07899878016847 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Required Intervention |