BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPRESS SPINAL IMPLANT SYSTEM

    MDR report key: 6309361 · Received February 7, 2017

    Report

    Report Number
    3005031160-2017-00113
    Event Type
    Malfunction
    Date Received
    February 7, 2017
    Date of Event
    January 11, 2017
    Report Date
    February 7, 2017
    Manufacturer
    X-SPINE SYSTEMS, INC.
    Product Code
    MNH
    PMA / PMN Number
    K120832
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THERE WERE NO CONSEQUENCES TO THE PATIENT DUE TO THIS INCIDENT, A SIMILAR INCIDENT COULD POTENTIALLY CAUSE A SERIOUS INJURY OR DEATH, IF THE INCIDENT WERE TO REOCCUR.

    Description of Event or Problem · 1

    DURING A MIS POSTERIOR SPINAL FUSION FROM L3 TO S1 ON (B)(6) 2017, THE SURGEON WAS USING THE ROD LENGTH INDICATOR TO MEASURE FOR A ROD, WHEN A PIECE OF THE DISTAL TIP OF THE INDICATOR WAS BROKEN OFF. THE PIECE OF THE INDICATOR FELL DOWN THE EXTENSION TOWER. THE SURGEON DIDN'T REALIZE THIS HAD HAPPENED UNTIL HE WAS TRYING TO PLACE THE ROD IN THE SCREW HEAD AND IT WOULDN'T GO DOWN INTO THE SCREW. THE SURGEON TRIED TO USE THE ROD REDUCER TO REDUCE THE ROD DOWN INTO THE SCREW, AND HE BROKE THE KNOB OFF OF THE REDUCER BY TURNING IT SO HARD. THE SURGEON THEN SAW THE FRAGMENT ON THE X-RAY AND TOOK THE TOWER EXTENDER OFF THE SCREW HEAD TO REMOVE THE PIECE OF THE TIP OF THE ROD INDICATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89465 XPRESS SPINAL IMPLANT SYSTEM SPINAL FUSION IMPLANT SYSTEM MNH X-SPINE SYSTEMS, INC. T073-0800 EM14G003

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other