BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CM DRIVE IMPLANT 3.5X11.5

    MDR report key: 8672377 · Received June 5, 2019

    Report

    Report Number
    3008261720-2019-02480
    Event Type
    Injury
    Date Received
    June 5, 2019
    Date of Event
    April 22, 2019
    Report Date
    June 5, 2019
    Manufacturer
    NEODENT - JJGC S.A.
    Product Code
    DZE
    UDI-DI
    07899878023449
    PMA / PMN Number
    K123022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER: E2015015. INSTRADENT USA, INC IS SUBMITTING THE REPORT ON BEHALF OF NEODENT - JJGC. CONSIDERING THE SURGICAL METHODOLOGY, IT WAS SEEN THAT THE DENTIST HAS SELECTED AN IMPLANT DESIGN WHICH IS NOT RECOMMENDED FOR THE PATIENT'S BONE QUALITY. 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.

    Description of Event or Problem · 0

    THE CLINICIAN REPORTED THAT 2.5 MONTHS AFTER THE 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 AND BLEEDING IN THIS PATIENT WITH EXCELLENT HYGIENE. 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 2.5 MONTHS AFTER THE 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 AND BLEEDING IN THIS PATIENT WITH EXCELLENT 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
    463952 CM DRIVE IMPLANT 3.5X11.5 ENDOSSEOUS DENTAL IMPLANT DZE NEODENT - JJGC S.A. 800306404I 07899878023449

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention MULTI-UNIT FULL ARCH PLACEMENT| MULTI-UNIT FULL ARCH PLACEMENT