BEUDAMED
    FDA Adverse Event Other Summary report: N

    6.5MM REVERE PEDICLE SCREW 40MM

    MDR report key: 856168 · Received May 24, 2007

    Report

    Report Number
    3004142400-2007-00003
    Event Type
    Other
    Date Received
    May 24, 2007
    Date of Event
    April 23, 2007
    Report Date
    May 24, 2007
    Manufacturer
    GLOBUS MEDICAL, INC.
    Product Code
    MCV
    PMA / PMN Number
    K061202
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL RESULTS / CONCLUSION: A FULL VISUAL AND DIMENSIONAL INSPECTION WAS PERFORMED ON THE PARTS IN QUESTION. ALL AVAILABLE DIMENSIONS WERE DISCOVERED TO BE WITHIN SPECS AND TOLERANCES. MANY OF THE DIMENSIONS COULD NOT BE MEASURED DUE TO THE DAMAGE THAT WAS DONE IN THE RETRIEVAL PROCESS. THE CRITICAL DIMENSIONS WOULD BE NECK DIAMETER AS WELL AS THE RADIUS OF THE TRANSITION FROM SCREW TO NECK DIAMETER AND NECK DIAMETER TO SPHERICAL HEAD. IT WAS SEEN THAT THE SCREW FRACTURED BELOW THE SPHERICAL HEAD PORTION OF THE SCREW. THESE SCREWS WERE IMPLANTED IN THE SACRUM DURING A LUMBAR FUSION. IT WAS DETERMINED IF THE FUSION WAS SUCCESSFUL. THE LENGTH OF TIME FROM THE FUSION TO THE REPORTED BREAKAGE WAS APPROX 5.5 MONTHS. THIS PT MAY PRESENT UNK CIRCUMSTANCES THAT PROVIDE SIGNIFICANT STRESSES TO THE PEDICLE SCREWS. BIOMECHANICALLY IT IS KNOWN THAT A SIGNIFICANT AMOUNT OF STRESS IS PRESENT WHEN ATTEMPTING TO FUSE L5 AND THE SACRUM. THIS IS ALSO SUPPORTED BY LITERATURE ON THE SUBJECT. MUCH OF THE TRUNK WEIGHT IS BORNE BY THIS ANATOMICAL STRUCTURE. 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 AND INORDINATE AMOUNT OF FORCE FOR AN EXTENDED PERIOD OF TIME. THIS CAN CAUSE A FATIGUE FAILURE. FROM THIS INVESTIGATION IT IS INDETERMINATE AS TO WHAT SPECIFICALLY CAUSED THE SCREW TO FAIL, ALTHOUGH THERE IS NO EVIDENCE THAT THE SCREW WAS MANUFACTURED INCORRECTLY.

    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 COMPLAINT PROCESSING FORM FROM GLOBUS MEDICAL, INC. 6.5MM REVERE PEDICLE SCREW 40MM. "TWO REVERE 6.5MM X 40MM BROKE AT THE SHANK OF THE SCREW POST-OPERATIVELY AFTER THE PATIENT HAD BEEN DISCHARGED FROM HOSPITAL. THE SCREWS WERE IMPLANTED IN 2006, WITH NO SIGNS OF MAL-PLACEMENT. IN 2007, THE SCREWS WERE REMOVED BECAUSE THEY WERE CAUSING LOW BACK PAIN IN PATIENT. XRAYS CONFIRMED SCREW BREAKAGE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6.5MM REVERE PEDICLE SCREW 40MM PEDICLE SCREW MCV GLOBUS MEDICAL, INC. 124.464 BGG215GE

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other