BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARA ACCESS NEEDLE

    MDR report key: 8674831 · Received June 6, 2019

    Report

    Report Number
    3012495575-2019-00001
    Event Type
    Malfunction
    Date Received
    June 6, 2019
    Date of Event
    February 26, 2019
    Report Date
    May 31, 2019
    Manufacturer
    SURGENTEC, LLC
    Product Code
    GDF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS THE OPINION OF THE MANUFACTURER, THE DEVICE MALFUNCTION WAS CAUSED BY THE SURGEON WHO WAS ADVANCING THE ALARA ACCESS NEEDLE (BY MALLETING) INTO THE PATIENT'S VERTEBRAL BODY BEYOND THE POINT WHERE THE SHEATH EXTENDED INTO BONE. THEN WITH THE SURGEON WAS ATTEMPTING TO REMOVE THE DEVICE BY MANUALLY MANIPULATING IT, AND A SNAP WAS HEARD. FURTHERING THE SURGICAL EVENT, IT WAS DETERMINED THAT PIECES OF THE SHEATH AND THE RADIOPAQUE RING REMAINED IN BODY.

    Description of Event or Problem · 1

    SURGEON HAD THE NEEDLE SET AT 3 WHICH EQUATES TO HAVING 30MM OF METAL EXPOSED BELOW THE DISTAL PLASTIC OUTER COVER. SURGEON IMPACTED THE NEEDLE ASSEMBLY APPROXIMATELY 20 MM INTO THE VERTEBRAL BODY AND A SNAP NOISE WAS HEARD. THE DEVICE MALFUNCTION WAS CAUSED BY THE SURGEON WHO WAS ADVANCING THE ALARA ACCESS NEEDLE (BY MALLETING) INTO THE PATIENT'S VERTEBRAL BODY BEYOND THE POINT WHERE THE SHEATH EXTENDED INTO BONE. THEN WITH THE SURGEON WAS ATTEMPTING TO REMOVE THE DEVICE BY MANUALLY MANIPULATING IT, AND A SNAP WAS HEARD. SURGEON TOOK AN IMAGE AND NOTED THAT 5MM OF THE DISTAL END OF THE NEEDLE WAS BROKEN OFF AND STUCK IN THE PATIENT'S PEDICLE. SURGEON ATTEMPTED TO REMOVE THE BROKEN PIECES (ADJUSTABLE SHEATH MADE OF XF 1022/9008 BLACK MATERIAL) BY SUCTION. A HOOK WAS THEN USED USE TO TRY AND REMOVE THE DISTAL METAL RING OF THE NEEDLE ASSEMBLY. SURGEON WAS UNABLE TO REMOVE THE RADIOPAQUE MARKER / RING MADE OF 304 STAINLESS STEEL. A PEDICLE SCREW WAS PLACED AND SECURED ON THE SAME PATH/TRAJECTORY AS THE NEEDLE ASSEMBLY. THIS ACTION ADVANCED THE RING/NEEDLE PLASTIC COMBINATION FORWARD. THE COMBINATION SITS APPROXIMATELY 5 MM DISTAL OF THE SCREW SHANK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467488 ALARA ACCESS NEEDLE GUIDE, NEEDLE, SURGICAL GDF SURGENTEC, LLC ALARA ACCESS NEEDLE 1320

    Patients

    Seq Age Sex Outcome Treatment
    1