BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INCLUSIVE TAPERED IMPLANT 5.2 X 13MM

    MDR report key: 3822246 · Received May 20, 2014

    Report

    Report Number
    3002195199-2014-00028
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    April 21, 2014
    Report Date
    May 20, 2014
    Manufacturer
    PRISMATIK DENTALCRAFT, INC.
    Product Code
    DZE
    PMA / PMN Number
    K121406
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    NINE MONTHS AFTER PLACEMENT, IMPLANTS FAILED..

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300768 INCLUSIVE TAPERED IMPLANT 5.2 X 13MM ENDOSSEOUS DENTAL IMPLANT DZE PRISMATIK DENTALCRAFT, INC. 6001455

    Patients

    Seq Age Sex Outcome Treatment
    1