BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LANX FUSION SYSTEM

    MDR report key: 3102410 · Received May 1, 2013

    Report

    Report Number
    3004485144-2013-00015
    Event Type
    Malfunction
    Date Received
    May 1, 2013
    Date of Event
    March 26, 2013
    Report Date
    May 1, 2013
    Manufacturer
    LANX, INC.
    Product Code
    MAX
    PMA / PMN Number
    073144
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: NO TESTING METHODS PERFORMED (RELATED DEVICE WAS BROKEN DURING USE). RESULTS: NO RESULTS AVAILABLE SINCE NO EVAL PERFORMED (RELATED DEVICE WAS BROKEN DURING USE). CONCLUSION: USER ERROR CAUSED OR CONTRIBUTED TO EVENT. LANX LABELING CONTAINS ADEQUATE INSTRUCTIONS RELATED TO PROPER IMPLANT SIZING AND SELECTION.

    Description of Event or Problem · 1

    DURING A FUSION PROCEDURE, A PEEK INTERBODY DEVICE BROKE IN HALF DURING ATTEMPTED IMPLANTATION. BOTH THE INSERTER BEING USED TO IMPLANT THE PEEK INTERBODY DEVICE AND THE PEEK INTERBODY DEVICE EXPERIENCED SIGNIFICANT FORCE APPLIED BY THE USER DURING IMPLANTATION. UPON REMOVAL OF THE BROKEN PEEK INTERBODY DEVICE, THE TWO HALVES BROKE INTO SEVERAL SMALLER PIECES. THE USER REMOVED ALL PIECES OF PEEK, RESULTING IN A TWO HR EXTENSION OF SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY USING A DIFFERENT PEEK INTERBODY DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190566 LANX FUSION SYSTEM PEEK INTERBODY DEVICE MAX LANX, INC. 8712-5010 L537880

    Patients

    Seq Age Sex Outcome Treatment
    1 INSERTER PN 8737-1001