BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREW GAUGE, LONG

    MDR report key: 1933405 · Received December 14, 2010

    Report

    Report Number
    9610622-2010-00545
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    November 30, 2010
    Report Date
    November 30, 2010
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    LXH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS DISCARDED BY THE HOSPITAL. NO EVAL WILL BE PERFORMED. IF ADD'L INFO BECOMES AVAILABLE IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED, THE WELDING ON THE T2/ GAMMA DEPTH GAUGE CAME APART. THE DEFECT WAS NOT AN ISSUE IN SURGERY AND COULD HAVE SIMPLY BEEN WEAR AND TEAR OF 5 YR OLD INSTRUMENT. THE INSTRUMENT WAS DISCARDED IN SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCREW GAUGE, LONG INSTRUMENT LXH STRYKER OSTEOSYNTHESIS KIEL NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other