BEUDAMED
    FDA Adverse Event Other Summary report: N

    6MM PIVOT POLYAXIAL PEDICLE SCREW, 40MM

    MDR report key: 844651 · Received February 28, 2007

    Report

    Report Number
    3004142400-2007-00001
    Event Type
    Other
    Date Received
    February 28, 2007
    Date of Event
    January 30, 2007
    Report Date
    February 26, 2007
    Manufacturer
    GLOBUS MEDICAL, INC.
    Product Code
    MCV
    PMA / PMN Number
    K040442
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS CONSIDERED AN UNUSUAL EVENT OR OCCURRENCE SINCE NO OTHER FAILURES HAVE BEEN REPORTED FOR THIS MEDICAL DEVICE. EVALUATION RESULTS/CONCLUSION: A FULL VISUAL AND DIMENSIONAL INSPECTION WAS PERFORMED ON THE PART IN QUESTION. ALL AVAILABLE DIMENSIONS WERE DISCOVERED TO BE WITHIN SPECIFICATIONS AND TOLERANCES. IT WAS SEEN THAT THE SCREW FRACTURED APPROX 10MM BELOW THE HEAD. THE FAILURE POINT WAS THEN PROBABLY WITHIN THE PEDICULAR REGION OF THE LUMBAR SPINE; AN AREA WHERE A SIGNIFICANT AMOUNT OF FORCE IS EXERTED BETWEEN THE IMPLANT AND THE BONY ANATOMY. THIS PARTICULAR SCREW WAS DESIGNED TO BE CANNULATED SUCH THAT IT COULD BE USED WITH A GUIDANCE TYPE INSTRUMENT SUCH AS A K-WIRE. THIS IS A CUSTOMARY AND COMMON SURGICAL TECHNIQUE TO INSERT THESE IMPLANTS. THE CANNULATION IS 1.8MM IN DIAMETER. BECAUSE OF THIS, THE DESIGN HAS A SHALLOWER THREAD DEPTH WHICH RESULTS IN A LARGER INNER DIAMETER OF THE SCREW. THEREFORE, THE CANNULATED SCREW HAS THE SAME STRENGTH AS A COMPARABLY SIZED SOLID SCREW. THE SCREW DESIGN WAS TESTED UNDER ALL APPLICABLE STANDARD TESTING AND DEEMED TO BE EQUAL OR GREATER IN STATIC AND FATIGUE STRENGTH. HOWEVER, WITHOUT THE ADDITION OF A SOLID FUSION MASS POST-OPERATIVELY, THE SCREW WILL BE REQUIRED TO WITHSTAND AN INORDINATE AMOUNT OF FORCE FOR AN EXTENDED PERIOD OF TIME. THIS CAN CAUSE A FATIGUE FAILURE. THIS PARTICULAR PT WAS A LARGER MALE AND MAY HAVE NEEDED A LARGER SCREW SIZE TO SUIT HIS ANATOMY. FROM THIS INVESTIGATION, IT IS INDETERMINATE AS TO WHAT SPECIFICALLY CAUSED THE SCREW TO FAIL, ALTHOUGH THERE IS NO EVIDENCE THAT THE SCREW WAS NOT MFR CORRECTLY.

    Description of Event or Problem · 1

    NOTE: GLOBUS MEDICAL, INC. WAS NOT AWARE IF HOSPITAL HAD SUBMITTED ANY MEDWATCH FORM FDA 3500A. THEREFORE, THE FOLLOWING "DESCRIBED EVENT OR PROBLEM" WAS TAKEN DIRECTLY OFF THE HOSPITAL DOCUMENTATION THAT WAS REQUESTED BY GLOBUS MEDICAL, INC. UPON HEARING OF THE COMPLAINT. 6MM PIVOT POLYAXIAL PEDICLE SCREW, 40MM. CT OF THE THORACOLUMBAR SPINE "THE RIGHT S1 PEDICLE SCREW IS FRACTURED, POSTERIORLY".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6MM PIVOT POLYAXIAL PEDICLE SCREW, 40MM POLYAXIAL PEDICLE SCREW MCV GLOBUS MEDICAL, INC. 123.464 BGF227HA

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other