BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITST ONE PIECE LAG SCREW

    MDR report key: 2042225 · Received February 15, 2011

    Report

    Report Number
    1822565-2011-00632
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    February 14, 2011
    Report Date
    February 15, 2011
    Manufacturer
    ZIMMER INC
    Product Code
    HSB
    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 WAS REPORTED THAT A HAIR WAS FOUND INSIDE THE STERILE PACKAGING DURING SURGERY. THE SURGEON USED A DIFFERENT SIZE OF IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ITST ONE PIECE LAG SCREW HSB ZIMMER INC 61491360

    Patients

    Seq Age Sex Outcome Treatment
    1