CM DRIVE ACQUA IMPLANT 4.3X13
Report
- Report Number
- 3008261720-2017-06589
- Event Type
- Injury
- Date Received
- November 22, 2017
- Date of Event
- October 19, 2017
- Report Date
- November 22, 2017
- Manufacturer
- NEODENT - JJGC S.A.
- Product Code
- DZE
- UDI-DI
- 07899878016892
- PMA / PMN Number
- K133592
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- DENTIST
Narratives
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. AFTER EVALUATION IT WAS SEEN THAT THE ITEM RECEIVED WAS NOT THE ITEM FIRST REPORTED.
THE CLINICIAN REPORTED THAT 4 MONTHS AFTER THE DENTAL IMPLANT WAS PLACED IN ADA SITE #10, NON-OSSEOINTEGRATION WAS OBSERVED IN A DIABETIC PATIENT WITH TYPE IV BONE. CLINICIAN NOTED POOR BONE QUALITY/QUANTITY AND PERFORMED A BONE GRAFT. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED POST-OPERATIVE COMPLICATIONS.
THE CLINICIAN REPORTED THAT 4 MONTHS AFTER THE DENTAL IMPLANT WAS PLACED IN ADA SITE #10, NON-OSSEOINTEGRATION WAS OBSERVED IN A DIABETIC PATIENT WITH TYPE IV BONE. CLINICIAN NOTED POOR BONE QUALITY/QUANTITY AND PERFORMED A BONE GRAFT. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED POST-OPERATIVE COMPLICATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 831150 | CM DRIVE ACQUA IMPLANT 4.3X13 | ENDOSSEOUS DENTAL IMPLANT | DZE | NEODENT - JJGC S.A. | 464701I | 07899878016892 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Required Intervention |