BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.0MM RIGID SCREW, SELF DRILLING, 16MM

    MDR report key: 1380945 · Received May 7, 2009

    Report

    Report Number
    3004142400-2009-00002
    Event Type
    Injury
    Date Received
    May 7, 2009
    Date of Event
    December 3, 2008
    Report Date
    April 10, 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 4.0 MM RIGID SCREW, SELF DRILLING, 16MM 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 SALES REPRESENTATIVE, VIA A COMPANY PROCESSING/EVALUATION FORM, THAT ONE (1) GLOBUS MANUFACTURED SCREW HAD BACKED OUT AFTER IMPLANTATION. IN 2008, A FEMALE PATIENT UNDERWENT A 4 LEVEL ACDF SURGERY. THE SURGEON IMPLANTED VARIABLE SCREWS SUPERIOR TO THE CONSTRUCT AND FIXED SCREWS AT THE INFERIOR PART OF THE CONSTRUCT. ON REVIEW OF A POST-OPERATIVE X-RAY, IT WAS REVEALED THAT ONE OF THE FIXED SCREWS HAD BACKED OUT. EIGHT MONTHS LATER, THE PATIENT UNDERWENT A SUBSEQUENT SURGERY AND THE SURGEON REMOVED A 4.0MM X 16MM FIXED ANGLE SCREW FROM THE ACDF. NEW 4.5MM X 14MM FIXED ANGLE SCREWS WERE THEN PLACED IN THE PATIENT WITH NO COMPLICATIONS. GLOBUS MEDICAL, INC. WAS NOTIFIED OF THE COMPLAINT ON 4/10/2009 BY A GLOBUS MEDICAL, INC. REPRESENTATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4.0MM RIGID SCREW, SELF DRILLING, 16MM ASSURE RIGID SCREW KWQ GLOBUS MEDICAL, INC. 110.016 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention