CM DRIVE IMPLANT 5.0X11.5
Report
- Report Number
- 3008261720-2018-00400
- Event Type
- Injury
- Date Received
- February 1, 2018
- Date of Event
- March 3, 2017
- Report Date
- September 5, 2018
- Manufacturer
- NEODENT - JJGC S.A.
- Product Code
- DZE
- UDI-DI
- 07898237569291
- PMA / PMN Number
- K123022
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ES
- 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 DENTIST REPORTED THAT 4 MONTHS AFTER THE DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION #6, ITS NON-OSSEOINTEGRATION WAS OBSERVED. THE IMPLANT WAS INSTALLED WITHOUT IMMEDIATELY LOAD. THE PATIENT PRESENTED BONE TYPE III.
(B)(4). THE DENTIST REPORTED THAT 4 MONTHS AFTER THE DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION #6, ITS NON-OSSEOINTEGRATION WAS OBSERVED. THE IMPLANT WAS INSTALLED WITHOUT IMMEDIATELY LOAD. THE PATIENT PRESENTED BONE TYPE III.
(B)(4). THE DENTIST REPORTED THAT 4 MONTHS AFTER THE DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION #6, ITS NON-OSSEOINTEGRATION WAS OBSERVED. THE IMPLANT WAS INSTALLED WITHOUT IMMEDIATELY LOAD. THE PATIENT PRESENTED BONE TYPE III.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 77122 | CM DRIVE IMPLANT 5.0X11.5 | ENDOSSEOUS DENTAL IMPLANT | DZE | NEODENT - JJGC S.A. | 33528I | 07898237569291 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Required Intervention |