BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIV CORTICAL SELF TAP SCREW

    MDR report key: 2516456 · Received March 30, 2012

    Report

    Report Number
    2648920-2012-00074
    Event Type
    Malfunction
    Date Received
    March 30, 2012
    Date of Event
    February 28, 2012
    Report Date
    February 29, 2012
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE CORTICAL SCREW WAS FRACTURED DURING SURGERY. THE SURGEON COULD REMOVE ONLY THE SCREW HEAD AND THE SHAFT WAS LEFT IN THE PT¿S BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TIV CORTICAL SELF TAP SCREW TRAUMA IMPLANT HWC ZIMMER MANUFACTURING B.V. 61905008

    Patients

    Seq Age Sex Outcome Treatment
    1