CM DRIVE IMPLANT 3.5X11.5
Report
- Report Number
- 3008261720-2019-01581
- Event Type
- Injury
- Date Received
- April 19, 2019
- Date of Event
- January 31, 2019
- Report Date
- July 5, 2019
- Manufacturer
- NEODENT - JJGC S.A.
- Product Code
- DZE
- UDI-DI
- 07898237568751
- PMA / PMN Number
- K123022
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- DENTIST
Narratives
ADDITIONAL PATIENT CODE (F10): 1690/ABSCESS. FOLLOW-UP IS BEING SENT TO INCLUDE CODE 50 IN FIELD H6 . THE COMPLAINT WAS RECEIVED BY MANUFACTURER AND, AFTER ANALYSIS, NEW INFORMATIONS WERE OBTAINED. A FOLLOW-UP IS BEING SENT TO CORRECT THESE INFORMATIONS ACCORDING TO THE EVALUATION MADE. AFTER THE EVALUATION WAS NOTICED THAT THE ITEM RECEIVED IS DIFFERENT FROM THE ITEM REPORTED. THEREFORE, THE ITEM WAS CORRECTED AND THE LOT NUMBER WAS NOT CONSIDERED.
ADDITIONAL PATIENT CODE: 1690/ABSCESS. EXEMPTION NUMBER: E2015015. INSTRADENT USA, INC IS SUBMITTING THE REPORT ON BEHALF OF NEODENT - JJGC. THE INFORMATION PROVIDED IN THIS REPORT WAS BASED ON INFORMATION GIVEN BY THE DENTIST IN NEODENT¿S PRODUCTS WARRANTY FORM THAT WAS RECORDED IN THE SYSTEM THAT IS USED BY BOTH THE MANUFACTURER AND THE SUBSIDIARY. THE ORIGINAL COMPLAINT AND THE PRODUCT WERE RECEIVED BY THE SUBSIDIARY AND DID NOT ARRIVE IN THE MANUFACTURER YET. WHEN THIS HAPPENS, A NEW EVALUATION OF THE COMPLAINT WILL BE CARRIED OUT AND, IF NECESSARY, A NEW FOLLOW-UP REPORT WILL BE SEND.
ADDITIONAL PATIENT CODE (F10): 1690/ABSCESS. EXEMPTION NUMBER: E2015015. INSTRADENT USA, INC IS SUBMITTING THE REPORT ON BEHALF OF NEODENT - JJGC.
THE CLINICIAN REPORTED THAT OVER 4 YEARS AFTER THE DENTAL IMPLANT WAS PLACED IN ADA SITE 8 IN THE MOUTH, THE IMPLANT LOST OSSEOINTEGRATION. THE CLINICIAN NOTED THE PATIENT'S PAIN, INFLAMMATION, ABSCESS AND A LOCAL INFECTION. THE SITE WAS GRAFTED. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED POST- OPERATIVE COMPLICATIONS.
THE CLINICIAN REPORTED THAT OVER 4 YEARS AFTER THE DENTAL IMPLANT WAS PLACED IN ADA SITE 8 IN THE MOUTH, THE IMPLANT LOST OSSEOINTEGRATION. THE CLINICIAN NOTED THE PATIENT'S PAIN, INFLAMMATION, ABSCESS AND A LOCAL INFECTION. THE SITE WAS GRAFTED. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED POST- OPERATIVE COMPLICATIONS.
THE CLINICIAN REPORTED THAT OVER 4 YEARS AFTER THE DENTAL IMPLANT WAS PLACED IN ADA SITE 8 IN THE MOUTH, THE IMPLANT LOST OSSEOINTEGRATION. THE CLINICIAN NOTED THE PATIENT'S PAIN, INFLAMMATION, ABSCESS AND A LOCAL INFECTION. THE SITE WAS GRAFTED. 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 |
|---|---|---|---|---|---|---|---|
| 324416 | CM DRIVE IMPLANT 3.5X11.5 | ENDOSSEOUS DENTAL IMPLANT | DZE | NEODENT - JJGC S.A. | 800138130 | 07898237568751 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Required Intervention | BONE GRAFT, PROSTHESIS PLACEMENT| BONE GRAFT, PROSTHESIS PLACEMENT| BONE GRAFT, PROSTHESIS PLACEMENT| BONE GRAFT, PROSTHESIS PLACEMENT |