BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.8MM Q-FIX IMPLANT, DISPOSABLE KIT, HIP

    MDR report key: 3871677 · Received April 16, 2014

    Report

    Report Number
    3006524618-2014-00115
    Event Type
    Malfunction
    Date Received
    April 16, 2014
    Date of Event
    March 19, 2014
    Report Date
    March 19, 2014
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    MBI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A HIP PROCEDURE USING A 1.8MM Q-FIX IMPLANT, THE IMPLANT FAILED TO DEPLOY FROM THE SHAFT. THE SURGEON OPTED TO COMPLETE THE PROCEDURE USING A COMPETITIVE DEVICE. THERE WERE NO SIGNIFICANT DELAYS OR PT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233802 1.8MM Q-FIX IMPLANT, DISPOSABLE KIT, HIP FIXATION ANCHOR, LIGAMENT, NON-BIODEGRAD MBI ARTHROCARE CORPORATION 1062684

    Patients

    Seq Age Sex Outcome Treatment
    1 Other