BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREW INSERTER HEX SHAFT

    MDR report key: 4144201 · Received April 28, 2014

    Report

    Report Number
    2032593-2014-00022
    Event Type
    Malfunction
    Date Received
    April 28, 2014
    Date of Event
    April 4, 2014
    Report Date
    April 4, 2014
    Manufacturer
    SEASPINE, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    THIS IS THE FIRST OF TWO REPORTS CONCERNING THE SCREW INSERTER HX SHAFT. IT WAS REPORTED THE SURGEON INSERTED SCREWS INTO PATIENT BOTH NEWPORT DRIVERS BROKE. ADDITIONAL INFORMATION WAS RECEIVED FROM THE DISTRIBUTOR. THE LIPS OF TWO DRIVERS BROKE INSIDE THE SCREW WHEN THE SCREW WAS INSERTED. THERE WAS NO REPORTED INJURY TO THE PATIENT BUT DUE TO THIS ISSUE, THE SURGERY WAS COMPLETED USING ONLY ONE ROD (UNILATERAL) INSTEAD OF TWO AND THE SURGERY TIME WAS EXTENDED 30 MINUTES AS THE TIP OF THE SPARE DEVICE ALSO BROKE AND THE SCREWS COULD NOT BE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254562 SCREW INSERTER HEX SHAFT SPINAL INSTRUMENTS-FIXED LXH SEASPINE, INC. M0162698

    Patients

    Seq Age Sex Outcome Treatment
    1