BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CM DRIVE IMPLANT 5.0X10

    MDR report key: 8532683 · Received April 19, 2019

    Report

    Report Number
    3008261720-2019-01580
    Event Type
    Injury
    Date Received
    April 19, 2019
    Date of Event
    January 9, 2019
    Report Date
    April 19, 2019
    Manufacturer
    NEODENT - JJGC S.A.
    Product Code
    DZE
    UDI-DI
    07898237569246
    PMA / PMN Number
    K123022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL PATIENT CODE (F10): 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 Manufacturer Narrative · 0

    ADDITIONAL PATIENT CODE (F10): 1690/ABSCESS. 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 3.5 YEARS AFTER THE DENTAL IMPLANT WAS PLACED IN ADA SITE 29 IN THE MOUTH, THE IMPLANT LOST OSSEOINTEGRATION. THE CLINICIAN NOTED THE PATIENT'S PAIN, MOBILITY, INFLAMMATION, AND ABSCESS. THE SITE WAS GRAFTED. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED POST-OPERATIVE COMPLICATIONS.

    Description of Event or Problem · 0

    THE CLINICIAN REPORTED THAT 3.5 YEARS AFTER THE DENTAL IMPLANT WAS PLACED IN ADA SITE 29 IN THE MOUTH, THE IMPLANT LOST OSSEOINTEGRATION. THE CLINICIAN NOTED THE PATIENT'S PAIN, MOBILITY, INFLAMMATION, AND ABSCESS. 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
    324418 CM DRIVE IMPLANT 5.0X10 ENDOSSEOUS DENTAL IMPLANT DZE NEODENT - JJGC S.A. 800157515 07898237569246

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention BONE GRAFT, DENTURE PLACEMENT| BONE GRAFT, DENTURE PLACEMENT| BONE GRAFT, DENTURE PLACEMENT