BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INCLUSIVE TAPERED IMPLANT

    MDR report key: 4183236 · Received October 17, 2014

    Report

    Report Number
    3002195199-2014-00075
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    April 23, 2014
    Report Date
    October 17, 2014
    Manufacturer
    PRISMATIK DENTALCRAFT, INC.
    Product Code
    DZE
    PMA / PMN Number
    K121406
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    THE PRODUCT WAS RETURNED STATING THAT THE IMPLANT FAILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660631 INCLUSIVE TAPERED IMPLANT DENTAL IMPLANT DZE PRISMATIK DENTALCRAFT, INC. 70-1070-IMP0011 6001389

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR