FDA Adverse Event
Injury
Summary report: N
ART. NO NOT REPORTED AT INITIAL REGISTRATION
MDR report key: 8693335
·
Received June 12, 2019
Report
- Report Number
- 3008261720-2019-02618
- Event Type
- Injury
- Date Received
- June 12, 2019
- Date of Event
- April 18, 2019
- Report Date
- June 12, 2019
- Manufacturer
- NEODENT - JJGC S.A.
- Product Code
- DZE
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- DENTIST
Narratives
Additional Manufacturer Narrative · 0
THE MISSING ARTICLE NUMBER AND LOT (BATCH) NUMBER WERE REQUESTED FROM THE INITIAL REPORTER. A FOLLOW UP REPORT WILL BE SUBMITTED UPON RECEIPT OF THE INFORMATION. EXEMPTION NUMBER: E2015015. INSTRADENT USA, INC IS SUBMITTING THE REPORT ON BEHALF OF NEODENT - JJGC.
Description of Event or Problem · 0
THE CLINICIAN REPORTED THAT LESS THAN 1 MONTH AFTER THE IMMEDIATE DENTAL IMPLANT WAS PLACED IN ADA SITE 19 IN THE PATIENT'S MOUTH, THE IMPLANT DID NOT ACHIEVE OSSEOINTEGRATION IN TYPE II BONE. THE CLINICIAN NOTED IMPLANT MOBILITY IN THIS PATIENT WITH EXCELLENT HYGIENE. THE SITE WAS GRAFTED. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED PATIENT COMPLICATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 487657 | ART. NO NOT REPORTED AT INITIAL REGISTRATION | ENDOSSEOUS DENTAL IMPLANT | DZE | NEODENT - JJGC S.A. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR | Required Intervention | BONE GRAFT, CROWN PLACEMENT| BONE GRAFT, CROWN PLACEMENT |