BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TARGET DEVICE 300X160MM /KH12212

    MDR report key: 2144041 · Received June 1, 2011

    Report

    Report Number
    9610622-2011-00235
    Event Type
    Malfunction
    Date Received
    June 1, 2011
    Date of Event
    April 28, 2011
    Report Date
    May 12, 2011
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    LXH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE REMAINS IMPLANTED. IF THE DEVICE OR ADDITIONAL INFO BECOMES AVAILABLE IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED, THE SURGEON IMPLANTED A GAMMA 3 NAIL ON (B)(6) 2011. HE WAS LOOKING AT POST OP FILMS AND SAW AN O-RING OR WASHER IN THE SOFT TISSUE OF THE PT ABOVE THE LEVEL OF THE GREATER TROCHE. THE SURGEON REQUESTED FOR US TO CHECK THE INSTRUMENTS AND NAILS TO SEE IF IT COULD BE OFF OF ANY ONE OF THOSE. AFTER CHECKING THE TARGETING ARM, THERE IS A C-CLAMP/WASHER MISSING OFF OF THE INSTRUMENT. THE SURGEON DOES NOT INTEND ANY FURTHER SURGICAL PROCEDURE FOR THIS PT AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TARGET DEVICE 300X160MM /KH12212 INSTRUMENT LXH STRYKER OSTEOSYNTHESIS KIEL NA KP246621

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Other