BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LANX SPINAL FIXATION SYSTEM

    MDR report key: 1705260 · Received May 28, 2010

    Report

    Report Number
    3004485144-2010-00007
    Event Type
    Injury
    Date Received
    May 28, 2010
    Date of Event
    April 30, 2010
    Report Date
    April 30, 2010
    Manufacturer
    LANX, INC
    Product Code
    KWQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO PERTAINING TO THE EVENT WAS REQUESTED BUT NOT PROVIDED BY THE INITIAL REPORTER, INCLUDING PT INFO AND THE DATE THE DEVICE WAS IMPLANTED. THE EXPLANTED DEVICE WAS RETURNED AND EVALUATED. THE FAILURE OCCURRED AT THE WEAKEST POINT OF THE SCREW COMPONENT, BETWEEN THE BONE THREADS AND THE POLYAXIAL HEAD. THE LOCATION OF THE BREAK IS CONSISTENT WITH A FAILURE CAUSED BY CYCLIC LOADING. ABSENCE OF BONY FUSION AS DESCRIBED BY THE INITIAL REPORTER APPEARS TO BE THE PROBABLE CAUSE FOR THE SCREW BREAK. THE DEVICE IS INTENDED FOR TEMPORARY FIXATION TO IMMOBILIZE AND STABILIZE THE SPINAL SEGMENTS WHILE AWAITING BONY FUSION TO TAKE PLACE. A LACK OF FUSION CAN LEAD TO MATERIAL FATIGUE AND EVENTUAL FAILURE OF THE IMPLANT.

    Description of Event or Problem · 1

    A PT UNDERWENT REVISION SPINAL SURGERY TO EXPLORE A NON-UNION RESULTING FROM A PREVIOUSLY IMPLANTED LEVEL L4/L5 CONSTRUCT. DURING THE REVISION THE SURGEON DISCOVERED A BROKEN PEDICLE SCREW AT L5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LANX SPINAL FIXATION SYSTEM SPINAL FIXATION SYSTEM KWQ LANX, INC 7715-7545 LX-2570A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention