BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6" 17G STRAIGHT DEK KIT

    MDR report key: 2561535 · Received April 25, 2012

    Report

    Report Number
    2648666-2012-00129
    Event Type
    Injury
    Date Received
    April 25, 2012
    Date of Event
    March 27, 2012
    Report Date
    March 27, 2012
    Manufacturer
    STRYKER INSTRUMENTS PUERTO RICO
    Product Code
    HRX
    PMA / PMN Number
    K032473
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN RECEIVED AT THE MFR FOR TESTING. AN EVAL WILL BE CONDUCTED UPON RECEIPT OF THE DEVICE, AND A FOLLOW-UP REPORT WILL BE SUBMITTED AFTER THE QUALITY INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEKOMPRESSOR FAILED TO FUNCTION (SEEMED JAMMED). WHEN THEY EXTRACTED THE DEKOMPRESSOR, THEY NOTED THAT THE TIP OF THE NEEDLE BROKE OFF INTO THE PT. THE SURGEON NEEDED TO MAKE AN INCISION IN ORDER TO EXTRACT THE TIP OF THE NEEDLE FROM THE PT. THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE. THERE WAS NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCES REPORTED RELATED TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6" 17G STRAIGHT DEK KIT HRX STRYKER INSTRUMENTS PUERTO RICO 12013012

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention