BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.5MM STRAIGHT ROD, 400MM

    MDR report key: 1381011 · Received May 4, 2009

    Report

    Report Number
    3004142400-2009-00001
    Event Type
    Injury
    Date Received
    May 4, 2009
    Date of Event
    April 6, 2009
    Report Date
    May 4, 2009
    Manufacturer
    GLOBUS MEDICAL, INC.
    Product Code
    KWQ
    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 COMPLAINT. A REVIEW WAS CONDUCTED OF ALL APPLICABLE MATERIAL RECORDS, MANUFACTURING RECORDS, STORAGE RECORDS, AND DISTRIBUTION RECORDS. ALL RECORDS REVEALED THE PRODUCT WAS MANUFACTURED WITHIN SPECIFICATIONS, AND MAINTAINED AND DISTRIBUTED IN ACCORDANCE WITH ALL FEDERAL, STATE AND OPERATING PROCEDURES. BASED ON RECORD REVIEW AND ALL AVAILABLE INFORMATION, IT IS DETERMINED THE REVERE 5.5 MM STRAIGHT ROD, 400MM DESIGN CONFORMED TO ALL APPLICABLE STANDARDS AND THERE WAS NO DEVIATION IN THE MANUFACTURE PROCESS. THERE IS NO INDICATION THIS ISSUE WAS A RESULT OF PRODUCT DEFECT OR MALFUNCTION.

    Description of Event or Problem · 1

    GLOBUS MEDICAL INC. RECEIVED NOTIFICATION FROM A REPRESENTATIVE, VIA A COMPANY PROCESSING/EVALUATION FORM, THAT A GLOBUS MANUFACTURED ROD HAD BROKEN AFTER IMPLANTATION. IN LATE 2007, THE PATIENT UNDERWENT THORACIC SPINE SURGERY UTILIZING TWO (2) REVERE RODS AND ADJUNCT HARDWARE. IN EARLY 2009, THE PATIENT HAD A ROUTINE POST-OP FILM TAKEN AND THE SURGEON SAW A BREAK IN ONE OF THE RODS. THREE MONTHS LATER, THE PATIENT UNDERWENT SURGERY TO HAVE THE BROKEN PORTION OF THE ROD REMOVED. DURING SURGERY, THE SURGEON CUT THE ROD AT THREE PLACES AND REMOVED THE BROKEN PIECE AND ANOTHER PIECE ABOVE. THE SURGEON SECURED THE REMAINING PORTION OF THE ROD WITH TWO IN-LINE CONNECTORS. GLOBUS MEDICAL INC. WAS NOTIFIED OF THE COMPLAINT THE SAME DAY BY A GLOBUS MEDICAL, INC. REPRESENTATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5.5MM STRAIGHT ROD, 400MM REVERE STRAIGHT ROD KWQ GLOBUS MEDICAL, INC. 124.520 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention