CM DRIVE ACQUA IMPL TI 5.0X10
Report
- Report Number
- 3008261720-2017-05227
- Event Type
- Injury
- Date Received
- November 14, 2017
- Date of Event
- April 17, 2017
- Report Date
- November 14, 2017
- Manufacturer
- NEODENT - JJGC S.A.
- Product Code
- DZE
- UDI-DI
- 07899878016861
- PMA / PMN Number
- K101207
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, 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.
THE CLINICIAN REPORTED THAT 4 MONTHS AFTER THE DENTAL IMPLANT WAS PLACED, IN ADA SITE #14 OF THE PATIENT'S MOUTH, NON-OSSEOINTEGRATIN WAS OBSERVED. THE PATIENT PRESENTED WITH BONE TYPE II. LOCAL INFECTION, PERIODONTAL DISEASE, POOR BONE QUALITY/QUANTITY AS WELL AS MOBILITY, BLEEDING AND BONE RESORPTION WERE INVOLVED IN THE EVENT. THE PATIENT IS ALLERGIC TO SULFA/NARCOTICS.
(B)(4). THE CLINICIAN REPORTED THAT 4 MONTHS AFTER THE DENTAL IMPLANT WAS PLACED, IN ADA SITE #14 OF THE PATIENT'S MOUTH, NON-OSSEOINTEGRATIN WAS OBSERVED. THE PATIENT PRESENTED WITH BONE TYPE II. LOCAL INFECTION, PERIODONTAL DISEASE, POOR BONE QUALITY/QUANTITY AS WELL AS MOBILITY, BLEEDING AND BONE RESORPTION WERE INVOLVED IN THE EVENT. THE PATIENT IS ALLERGIC TO SULFA/NARCOTICS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 808948 | CM DRIVE ACQUA IMPL TI 5.0X10 | ENDOSSEOUS DENTAL IMPLANT | DZE | NEODENT - JJGC S.A. | 800180651I | 07899878016861 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Required Intervention |