BEUDAMED
    FDA Adverse Event Other Summary report: N

    7.5MM REVERE PEDICLE SCREW 40MM

    MDR report key: 991327 · Received January 31, 2008

    Report

    Report Number
    3004142400-2008-00001
    Event Type
    Other
    Date Received
    January 31, 2008
    Date of Event
    December 3, 2007
    Report Date
    January 23, 2008
    Manufacturer
    GLOBUS MEDICAL, INC.
    Product Code
    MCV
    PMA / PMN Number
    K061202
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPREHENSIVE INVESTIGATION WAS IMMEDIATELY INITIATED ON RECEIPT OF THE REPORT. ALTHOUGH THE SCREW WAS NOT RETURNED FOR EVAL, A COMPREHENSIVE REVIEW WAS CONDUCTED OF ALL APPLICABLE MATERIAL RECORDS, MFG RECORDS, STORAGE RECORDS, AND DISTRIBUTION RECORDS. ALL RECORDS REVEALED THE PRODUCTS WERE MFG WITHIN SPECIFICATIONS, MAINTAINED AND DISTRIBUTED IN ACCORDANCE WITH ALL FEDERAL, STATE AND OPERATING PROCEDURES. THE REPORT STATES APPROX 9 MONTHS HAD ELAPSED FROM IMPLANTATION AND EVIDENCE OF A BREAKAGE. THERE ARE MANY PT FACTORS THAT CAN CONTRIBUTE TO A SCREW BREAKAGE DURING THIS TIME AND THE PACKAGE INSERT WARNS THAT "THE PT'S WEIGHT AND ACTIVITY HAVE AN EFFECT ON THE STRESSES OF THE IMPLANT" AND "PT'S ANATOMY SHOULD BE CONSIDERED WHEN SELECTING SCREW DIAMETER AND LENGTH." ADDITIONALLY, PUBLISHED STUDIES INDICATE THAT SCREWS UTILIZED IN THIS ANATOMICAL AREA HAVE FAILURE RATES AS HIGH AS 12.4%, "THE USE OF PEDICLE-SCREW INTERNAL FIXATION FOR THE OPERATIVE TREATMENT OF SPINAL DISORDERS," ROBERT W GAINES JR, JBJS AM. 2000:82:1458; "COMPLICATIONS OF PEDICLE SCREWS IN LUMBAR AND LUMBOSACRAL FUSION IN 105 CONSECUTIVE PRIMARY OPERATIONS," P.C. JUTTE, R.M. CASTELEIN, EUR SPINE J, 2002011:594-598. BASED ON RECORD REVIEW AND ALL AVAILABLE INFO, IT WAS DETERMINED THE REVERE SCREW DESIGN CONFORMS TO ALL APPLICABLE STANDARDS AND THERE WAS NO DEVIATION IN THE MFR PROCESS. THERE IS NO INDICATION THE BREAKAGE WAS A RESULT OF PROD DEFECT, MALFUNCTION, OR POSES ANY INJURY WITH USE. ALL RECORDS PURPORT THE SCREW WAS OF THE HIGHEST QUALITY AND SAFETY.

    Description of Event or Problem · 1

    GLOBUS MEDICAL RECEIVED NOTIFICATION FROM A DISTRIBUTOR, VIA A COMPANY PROCESSING / EVAL FORM, THAT A GLOBUS MFG SCREW HAD BROKEN AFTER IMPLANTATION. THE ONLY INFO REPORTED IS THAT A MALE PT HAD BEEN IMPLANTED IN 2007 WITH PEDICLE SCREWS AND BILATERAL PLIF CAGES AT L5-S1. APPROXIMATELY, ABOUT 10 MONTHS LATER, A SURGEON HAD NOTICED A "BROKEN SCREW IN THE SACRUM" "WHILE EXPLORING A FUSION MASS." THE SCREW WAS EXPLANTED DURING THE SURGERY. THE SCREW WAS NOT RETURNED TO GLOBUS FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 7.5MM REVERE PEDICLE SCREW 40MM PEDICLE SCREW MCV GLOBUS MEDICAL, INC. 124.474 BGG138FC

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other