CM DRIVE IMPLANT 4.3X16
Report
- Report Number
- 3008261720-2019-00783
- Event Type
- Injury
- Date Received
- February 26, 2019
- Date of Event
- December 14, 2018
- Report Date
- April 11, 2019
- Manufacturer
- NEODENT - JJGC S.A.
- Product Code
- DZE
- UDI-DI
- 07899878023340
- PMA / PMN Number
- K123022
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- DENTIST
Narratives
ADDITIONAL PATIENT CODE (DESCRIPTION) IN F10: 1690/ABSCESS. EXEMPTION NUMBER: E2015015. INSTRADENT USA, INC IS SUBMITTING THE REPORT ON BEHALF OF NEODENT - JJGC. THE INVESTIGATION OF THE COMPLAINT WAS CARRIED OUT CONSIDERING THE ANALYSIS OF THE INFORMATION GIVEN BY THE DENTIST IN THE GUARANTEE FORM, VISUAL CONFERENCE OF THE PRODUCT RETURNED BY THE DENTIST AND THE EVALUATION OF RELEVANT PRODUCTION RECORDS.
ADDITIONAL PATIENT CODE (DESCRIPTION) IN F10: 1690/ABSCESS. EXEMPTION NUMBER: E2015015. INSTRADENT USA, INC IS SUBMITTING THE REPORT ON BEHALF OF NEODENT - JJGC. FOLLOW UP BEING SENT TO JUSTIFY THE ABSENCE OF THE LOT NUMBER. 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. THE INVESTIGATION OF THE COMPLAINT WAS CARRIED OUT CONSIDERING THE ANALYSIS OF THE INFORMATION GIVEN BY THE DENTIST IN THE GUARANTEE FORM, VISUAL CONFERENCE OF THE PRODUCT RETURNED BY THE DENTIST AND THE EVALUATION OF RELEVANT PRODUCTION RECORDS.
AADDITIONAL PATIENT CODE (DESCRIPTION) IN F10: 1690/ABSCESS. EXEMPTION NUMBER: E2015015. INSTRADENT USA, INC IS SUBMITTING THE REPORT ON BEHALF OF NEODENT - JJGC.
THE CLINICIAN REPORTED THAT OVER 4 MONTHS AFTER THE DENTAL IMPLANT WAS PLACED IN THE MOUTH, THE IMPLANT DID NOT OSSEOINTEGRATE IN TYPE III BONE. CLINICIAN REPORTS THE PATIENT'S INFECTION, ABSCESS, INSUFFICIENT BONE QUALITY/QUALITY AND GOOD HYGIENE. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED POST- OPERATIVE COMPLICATIONS. (B)(4).
THE CLINICIAN REPORTED THAT OVER 4 MONTHS AFTER THE DENTAL IMPLANT WAS PLACED IN THE MOUTH, THE IMPLANT DID NOT OSSEOINTEGRATE IN TYPE III BONE. CLINICIAN REPORTS THE PATIENT'S INFECTION, ABSCESS, INSUFFICIENT BONE QUALITY/QUALITY AND GOOD HYGIENE. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED POST- OPERATIVE COMPLICATIONS. (B)(4).
THE CLINICIAN REPORTED THAT OVER 4 MONTHS AFTER THE DENTAL IMPLANT WAS PLACED IN THE MOUTH, THE IMPLANT DID NOT OSSEOINTEGRATE IN TYPE III BONE. CLINICIAN REPORTS THE PATIENT'S INFECTION, ABSCESS, INSUFFICIENT BONE QUALITY/QUALITY AND GOOD HYGIENE. 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 |
|---|---|---|---|---|---|---|---|
| 165195 | CM DRIVE IMPLANT 4.3X16 | ENDOSSEOUS DENTAL IMPLANT | DZE | NEODENT - JJGC S.A. | 800325539I | 07899878023340 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |