BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INCLUSIVE HANDPIECE IMPLANT DRIVER, SHORT

    MDR report key: 3816842 · Received May 19, 2014

    Report

    Report Number
    3002195199-2014-00026
    Event Type
    Malfunction
    Date Received
    May 19, 2014
    Report Date
    May 14, 2014
    Manufacturer
    PRISMATIK DENTALCRAFT, INC.
    Product Code
    DZN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    THE DENTAL IMPLANT HEX ROUNDED OUT DUE TO THE IMPLANT DRIVER. IMPLANT WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295265 INCLUSIVE HANDPIECE IMPLANT DRIVER, SHORT IMPLANT DRIVER DZN PRISMATIK DENTALCRAFT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1