BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INCLUSIVE TAPERED IMPLANT 3.7 X 10MM

    MDR report key: 3910862 · Received July 2, 2014

    Report

    Report Number
    3002195199-2014-00042
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Report Date
    June 30, 2014
    Manufacturer
    PRISMATIK DENTALCRAFT, INC.
    Product Code
    DZE
    PMA / PMN Number
    K121406
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    THE IMPLANT FAILED TO INTEGRATE INTO THE BODY. THE DR. STATED THE PATIENT'S BONE COULD NOT SUPPORT THE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387792 INCLUSIVE TAPERED IMPLANT 3.7 X 10MM ENDOSSEOUS DENTAL IMPLANT DZE PRISMATIK DENTALCRAFT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1