BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARALLAX CLEARVIEW ACCESS NEEDLE

    MDR report key: 2852938 · Received November 27, 2012

    Report

    Report Number
    3006524618-2012-00925
    Event Type
    Malfunction
    Date Received
    November 27, 2012
    Date of Event
    October 29, 2012
    Report Date
    October 30, 2012
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A KYPHOPLASTY SPINE PROCEDURE USING THE PARALLAX CLEARVIEW ACCESS NEEDLE, THE DEVICE BROKE INSIDE THE PATIENT. THE SURGEON WAS UNABLE TO UNSCREW THE DEVICE TO REMOVE IT, SO IT HAD TO BE RETRIEVED USING A PAIR OF PLIERS. THE PROCEDURE WAS REPORTED T OBE COMPLETED WITHOUT SIGNIFICANT DELAY OR FURTHER PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARALLAX CLEARVIEW ACCESS NEEDLE CANNULAE GEI ARTHROCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other