BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LANX SPINAL FIXATION SYSTEM

    MDR report key: 2036732 · Received February 18, 2011

    Report

    Report Number
    3004485144-2011-00022
    Event Type
    Malfunction
    Date Received
    February 18, 2011
    Report Date
    February 20, 2011
    Manufacturer
    LANX, INC.
    Product Code
    MNI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL EXAMINATION OF THE BROKEN SCREW 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 INFORMATION REC'D, BONY FUSION WAS ACHIEVED SOMETIME DURING THE 16-MONTHS FOLLOWING IMPLANTATION OF THE DEVICE. HOWEVER, THE TIME AT WHICH THE SCREW BREAK OCCURRED, RELATIVE TO BONY FUSION, CANNOT BE CONCLUSIVELY DETERMINED. THE DEVICE LABELING (IFU7721-0210CE.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 UNDERTAKEN 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."

    Description of Event or Problem · 1

    DURING A PLANNED REMOVAL OF A LUMBAR SPINAL FUSION CONSTRUCT FOLLOWING FUSION, THE SURGEON DISCOVERED THAT ONE OF THE PEDICLE SCREWS WAS BROKEN AT THE SCREW SHANK JUST BELOW THE SCREW HOUSING. THE SURGEON REMOVED THE L5-S1 PEDICLE SCREW CONSTRUCT, BUT CHOSE TO LEAVE THE SCREW REMNANT IN THE L5 PEDICLE. PER THE INITIAL REPORTER, THE SURGEON WAS NOT CONCERNED WITH ANY COMPLICATION FROM THE REMNANT. IT WAS OBSERVED THAT BONY FUSION WAS ACHIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LANX SPINAL FIXATION SYSTEM SPINAL FIXATION SYSTEM MNI LANX, INC. 7716-7545 LX-1583

    Patients

    Seq Age Sex Outcome Treatment
    1 ALLOGRAFT| SPINOUS PROCESS FUSION PLATE