BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LANX SPINAL FIXATION SYSTEM

    MDR report key: 1676092 · Received May 3, 2010

    Report

    Report Number
    3004485144-2010-00003
    Event Type
    Injury
    Date Received
    May 3, 2010
    Date of Event
    February 10, 2010
    Report Date
    February 10, 2010
    Manufacturer
    LANX, INC
    Product Code
    KWQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT MADE AVAILABLE FOR EVALUATION. IT APPEARS THAT THE LACK OF FUSION CONTRIBUTED TO THE IMPLANT BREAKAGE. PER THE DEVICE LABELING, THE DEVICE IS INTENDED FOR TEMPORARY FIXATION TO IMMOBILIZE AND STABILIZE THE SPINAL SEGMENTS WHILE AWAITING BONY FUSION TO TAKE PLACE. AFTER SOLID FUSION OCCURS, THE SYSTEM SERVES NO FUNCTIONAL PURPOSE. A LACK OF FUSION CAN LEAD TO MATERIAL FATIGUE AND EVENTUAL FAILURE OF THE IMPLANT. THIS EVENT WAS REPORTED AFTER RECEIVING ADDITIONAL GUIDANCE FROM THE FDA REPORTING SYSTEMS MONITORING BRANCH ON 04/22/2010 RELATIVE TO REPORTING REQUIREMENTS.

    Description of Event or Problem · 1

    A PATIENT UNDERWENT A REVISION SURGERY TO REMOVE A BROKEN PEDICLE SCREW. THE HARDWARE WAS IMPLANTED IN EARLY 2008 AT A SINGLE LEVEL. ALL OTHER HARDWARE WAS REPORTEDLY INTACT. BASED ON INFORMATION RECEIVED, THERE IS AN INDICATION THAT FUSION MIGHT NOT HAVE OCCURRED. THE ENTIRE HARDWARE CONSTRUCT WAS REPLACED DURING THE REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LANX SPINAL FIXATION SYSTEM SPINAL FIXATION SYSTEM KWQ LANX, INC 7716-6540

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention DEMINERALIZED BONE MATRIX| PEEK INTERBODY SPACER