BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6.5MM REVERE PREFERRED ANGLE MONOAXIAL SCREW

    MDR report key: 1575030 · Received December 31, 2009

    Report

    Report Number
    3004142400-2009-00008
    Event Type
    Injury
    Date Received
    December 31, 2009
    Date of Event
    December 2, 2009
    Report Date
    December 2, 2009
    Manufacturer
    GLOBUS MEDICAL, INC.
    Product Code
    NQP
    Adverse Event
    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 COMPLAINT. A REVIEW WAS CONDUCTED OF ALL APPLICABLE MATERIAL RECORDS, MANUFACTURING RECORDS, STORAGE RECORDS, AND DISTRIBUTION RECORDS. ADDITIONALLY, A DEVICE FROM THE SAME LOT OF THE ACTUAL DEVICE INVOLVED IN THE INCIDENT WAS EVALUATED. ALL RECORDS REVEALED THE PRODUCT WAS MANUFACTURED WITHIN SPECIFICATIONS, MAINTAINED AND DISTRIBUTED IN ACCORDANCE WITH ALL FEDERAL, STATE AND OPERATING PROCEDURES. BASED ON RECORD REVIEW, EVALUATION, AND ALL AVAILABLE INFORMATION, IT IS DETERMINED THE 6.5MM REVERE PREFERRED ANGLE MONAXIAL SCREW 35MM DESIGN CONFORMS TO ALL APPLICABLE STANDARDS AND THERE IS NO INDICATION THE ISSUE WAS A RESULT OF PRODUCT DEFECT OR MALFUNCTION.

    Description of Event or Problem · 1

    GLOBUS MEDICAL, INC RECEIVED NOTIFICATION FROM A SALES REPRESENTATIVE, VIA TELEPHONE COMMUNICATION, THAT TWO GLOBUS MANUFACTURED SCREWS HAD BROKEN AFTER IMPLANTATION. IN 2009, A PATIENT UNDERWENT POSTERIOR LUMBAR FUSION USING TLIF, SIX GLOBUS MEDICAL REVERE SCREWS AND TWO TRANSITION RODS WERE IMPLANTED. SUBSEQUENT TO THE SURGERY, THE PATIENT WAS RECEIVING PHYSICAL THERAPY AND IN A MANEUVER THAT PUSHED THE PATIENT'S FEET TOWARD HER HEAD, SHE REPORTED HEARING A CRACK. X-RAYS WERE TAKEN AND REVEALED BILATERAL SCREW BREAKAGE AT S1. EIGHT MONTHS LATER, THE SURGEON REMOVED THE TWO BROKEN SCREWS AND REPLACED THE BROKEN SCREWS WITH TWO LARGER DIAMETER 7.5X35MM SCREWS AND INSTALLED NEW TRANSITION RODS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6.5MM REVERE PREFERRED ANGLE MONOAXIAL SCREW REVERE PREFERRED ANGLE MONOAXIAL SCREW NQP GLOBUS MEDICAL, INC. 124.802 BTJ288BB

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention TRANSITION RODS| SUSTAIN-R ARCH| 11MM SPACER