CM DRIVE IMPL TI 3.5X8
Report
- Report Number
- 3008261720-2017-05058
- Event Type
- Injury
- Date Received
- November 15, 2017
- Date of Event
- March 31, 2017
- Report Date
- January 17, 2018
- Manufacturer
- NEODENT - JJGC S.A.
- Product Code
- DZE
- UDI-DI
- 07898237569307
- PMA / PMN Number
- K123022
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NV, 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.
EXEMPTION NUMBER: E2015015. INSTRADENT USA, INC IS SUBMITTING THE REPORT ON BEHALF OF NEODENT - JJGC.
(B)(4) - THE CLINICIAN REPORTED THAT NEARLY THREE MONTHS AFTER THE DENTAL IMPLANT WAS PLACED, IN ADA SITE #7 OF THE PATIENT¿S MOUTH, NON-OSSEOINTEGRATION WAS OBSERVED. THE DEVICE WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED PATIENT INJURIES OR COMPLICATIONS.
THE CLINICIAN REPORTED THAT NEARLY THREE MONTHS AFTER THE DENTAL IMPLANT WAS PLACED, IN ADA SITE #7 OF THE PATIENT¿S MOUTH, NON-OSSEOINTEGRATION WAS OBSERVED. THE DEVICE WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED PATIENT INJURIES OR COMPLICATIONS
(B)(4). THE CLINICIAN REPORTED THAT NEARLY THREE MONTHS AFTER THE DENTAL IMPLANT WAS PLACED, IN ADA SITE #7 OF THE PATIENT¿S MOUTH, NON-OSSEOINTEGRATION WAS OBSERVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 812058 | CM DRIVE IMPL TI 3.5X8 | ENDOSSEOUS DENTAL IMPLANT | DZE | NEODENT - JJGC S.A. | 800193417I | 07898237569307 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Required Intervention |