BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INCLUSIVE TAPERED IMPLANT 4.7 X 13MM (2)

    MDR report key: 3910887 · Received July 2, 2014

    Report

    Report Number
    3002195199-2014-00043
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Report Date
    July 1, 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

    FAILED IMPLANTS

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386986 INCLUSIVE TAPERED IMPLANT 4.7 X 13MM (2) ENDOSSEOUS DENTAL IMPLANT DZE PRISMATIK DENTALCRAFT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1