BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TITANIUM ABUTMENT 6 MMH COMPATIBLE WITH: STRAUMANN® BONE LEVEL RC

    MDR report key: 4201267 · Received October 27, 2014

    Report

    Report Number
    3002195199-2014-00076
    Event Type
    Malfunction
    Date Received
    October 27, 2014
    Report Date
    October 24, 2014
    Manufacturer
    PRISMATIK DENTALCRAFT, INC.
    Product Code
    NHA
    PMA / PMN Number
    K083192
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER STATES THAT ABUTMENT BROKE JUST ABOVE COLLAR. IT BROKE CLEAN THROUGH SO THE CROWN IS STILL CEMENTED TO ABUTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681970 TITANIUM ABUTMENT 6 MMH COMPATIBLE WITH: STRAUMANN® BONE LEVEL RC TITANIUM ABUTMENT 6 MMH COMPATIBLE WITH: STRAUMANN® BONE LEVEL RC NHA PRISMATIK DENTALCRAFT, INC. 70-1052-COM0004 6011080

    Patients

    Seq Age Sex Outcome Treatment
    1