BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INCLUSIVE TAPERED IMPLANT 4.7 X 11.5MM

    MDR report key: 3896708 · Received June 26, 2014

    Report

    Report Number
    3002195199-2014-00040
    Event Type
    Malfunction
    Date Received
    June 26, 2014
    Date of Event
    February 25, 2014
    Report Date
    June 25, 2014
    Manufacturer
    PRIZMATIK DENTALCRAFT, INC.
    Product Code
    DZE
    PMA / PMN Number
    K121406
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    DENTAL IMPLANT FAILED TO OSSEOINTEGRATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373297 INCLUSIVE TAPERED IMPLANT 4.7 X 11.5MM ENDOSSEOUS DENTAL IMPLANT DZE PRIZMATIK DENTALCRAFT, INC. 6001433

    Patients

    Seq Age Sex Outcome Treatment
    1