BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LANX SPINAL FIXATION SYSTEM

    MDR report key: 2066240 · Received March 30, 2011

    Report

    Report Number
    3004485144-2011-00029
    Event Type
    Malfunction
    Date Received
    March 30, 2011
    Date of Event
    March 2, 2011
    Report Date
    March 2, 2011
    Manufacturer
    LANX, INC.
    Product Code
    MNI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL EXAM OF THE BROKEN SCREWS INDICATES THAT 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 AND FATIGUE. BASED ON INFO RECEIVED, SOME BONY FUSION WAS ACHIEVED DURING THE THIRTY MONTHS FOLLOWING IMPLANTATION OF THE CONSTRUCT. PT CONDITION (I.E., SMOKER, OVERWEIGHT, PROGRESSION OF DISEASE) MAY HAVE CONTRIBUTED TO LIMITED FUSION. THE TIME AT WHICH THE SCREW BREAKS OCCURRED RELATIVE TO BONY FUSION COULD NOT BE DETERMINED. THE DEVICE LABELING (IFU7721-0310CE.01) PROVIDES THE FOLLOWING DESCRIPTION: "AFTER A SOLID FUSION OCCURS, THE SYSTEM SERVES NO FUNCTIONAL PURPOSE AND SHOULD BE REMOVED."; AND THE FOLLOWING CAUTIONS: " BASED ON THE FATIGUE TESTING RESULTS, THE PHYSICIAN/SURGEON MUST CONSIDER THE LEVELS OF IMPLANTATION, PT WEIGHT, PT ACTIVITY LEVEL, OTHER PT CONDITIONS, ETC. WHICH MAY IMPACT ON THE PERFORMANCE OF THE SYSTEM. IT IS RECOMMENDED THAT REGULAR POSTOPERATIVE F/U IS UNDER TAKEN TO DETECT EARLY SIGNS OF FAILURE OF THE IMPLANTS AND TO CONSIDER THE ACTION TO BE TAKEN. DETERIORATION OF THE DEVICE AFTER BONE CONSOLIDATION CANNOT BE CONSIDERED TO CONSTITUTE A DYSFUNCTION OR DETERIORATION IN THE CHARACTERISTICS OF THE IMPLANTS. THE IMPLANT CAN BE REMOVED AFTER BONY HEALING." OTHER: PT'S CONDITION AND FATIGUE CONTRIBUTED TO FAILURE OF THE DEVICE.

    Description of Event or Problem · 1

    DURING A F/U LUMBAR FUSION SURGERY TO REMOVE ORIGINAL HARDWARE AT L4-L5 AND EXTEND FUSION TO L3-L4, THE SURGEON DISCOVERED THAT THE SHANK OF TWO PEDICLE SCREWS AT L5 WERE BROKEN JUST BELOW THE HEAD OF THE SCREW. THE TIME AT WHICH THE BREAKAGE OCCURRED IS UNK. A/P AND LATERAL FILMS TAKEN PRIOR TO THE SURGERY DID NOT REVEAL THE SCREWS WERE BROKEN. THE ORIGINAL SURGERY WAS PERFORMED (B)(6) 2008. THE BROKEN SCREWS WERE REPLACED AND THE FIXATION WAS EXTENDED TO INCLUDE PLIF AT L3-L4. THE REPORTER NOTED THAT INTERBODY FUSION AT L4-L5 HAD OCCURRED, BUT THE POSTEROLATERAL FUSION AT THIS LEVEL WAS INCOMPLETE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LANX SPINAL FIXATION SYSTEM SPINAL FIXATION SYSTEM MNI LANX, INC. 7715-6535 LX-2739

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR ALLOGRAFT