BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER SELF-TAPPING BONE SCREW

    MDR report key: 3142819 · Received May 24, 2013

    Report

    Report Number
    2648920-2013-00119
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Date of Event
    February 15, 2013
    Report Date
    April 25, 2013
    Manufacturer
    ZIMMER
    Product Code
    MRA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS RECEIVED FROM A FOREIGN SOURCE WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE SCREW HEAD BROKE WHILE TIGHTENING. THE FRACTURED PART REMAINS IN THE PT'S FEMUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232702 ZIMMER SELF-TAPPING BONE SCREW MRA ZIMMER 62115754

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR