BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LANX SPINAL FIXATION SYSTEM

    MDR report key: 1931955 · Received November 30, 2010

    Report

    Report Number
    3004485144-2010-00054
    Event Type
    Malfunction
    Date Received
    November 30, 2010
    Date of Event
    October 26, 2010
    Report Date
    November 1, 2010
    Manufacturer
    LANX, INC.
    Product Code
    KWQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS NOT RETURNED FOR EVAL. ACCORDING TO THE INITIAL REPORTER, FULL FUSION AT THE ORIGINAL LEVEL MAY HAVE COMPLICATED THE REMOVAL TECHNIQUE. AT THE TIME OF THE BREAK, THE COUNTER TORQUE INSTRUMENT WAS NOT ENGAGED WITH THE CONSTRUCT, WHICH RESULTED IN EXCESSIVE FORCE APPLIED TO THE SCREW SHANK DURING SET SCREW REMOVAL. AS DESCRIBED IN THE DEVICE INSTRUCTION FOR USE THE COUNTER TORQUE INSTRUMENT MUST BE ENGAGED WITH THE ROD DURING THE SET SCREW TIGHTENING OR REMOVAL SEQUENCE.

    Description of Event or Problem · 1

    DURING A SECOND SPINAL SURGERY TO EXTEND FIXATION FROM THE ORIGINAL LEVEL L5/S1 TO L4/L5, THE SURGEON BROKE THE SHANK OF A PEDICLE SCREW WHEN ATTEMPTING TO REMOVE THE SET SCREW FROM THE SCREW HOUSING. THE INCIDENT ADDED APPROX 20 MINUTES TO THE SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT INJURY TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LANX SPINAL FIXATION SYSTEM SPINAL FIXATION SYSTEM KWQ LANX, INC. 7716-6545

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR