BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XPAND SPACER LARGE 25X32 4/4 39-41MME

    MDR report key: 1246672 · Received November 26, 2008

    Report

    Report Number
    3004142400-2008-00010
    Event Type
    Injury
    Date Received
    November 26, 2008
    Date of Event
    October 27, 2008
    Report Date
    November 26, 2008
    Manufacturer
    GLOBUS MEDICAL, INC.
    Product Code
    MQP
    PMA / PMN Number
    K050850
    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. ADDITIONALLY, A CAUSE AND EFFECT ANALYSIS AND FMEA WAS PERFORMED. ALL RECORDS REVEALED THE PRODUCT WAS MANUFACTURED WITHIN SPECIFICATIONS, MAINTAINED AND DISTRIBUTED IN ACCORDANCE WITH ALL FEDERAL, STATE AND OPERATING PROCEDURES. BASED ON A RECORD REVIEW AND ALL AVAILABLE INFORMATION, IT IS DETERMINED THE XPAND SPACER LARGE 25X32 4/4º 39-41MME DESIGN CONFORMS TO ALL APPLICABLE STANDARDS AND THERE WAS NO DEVIATION IN THE MANUFACTURE PROCESS. THERE IS NO INDICATION THAT THE COLLAPSE 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 SPACER HAD COLLAPSED AFTER IMPLANTATION. THE PATIENT UNDERWENT SPINAL SURGERY IN 2008 AND RECEIVED THE XPAND SPACER IMPLANT. IT WAS OBSERVED ON THE 2 MONTH FOLLOW UP X-RAYS THAT THE IMPLANTED SPACER HAD "DECREASED IN HEIGHT." INSPECTION OF THE X-RAYS REVEALED THAT A REVISION WAS NECESSARY. REVISION SURGERY WAS PERFORMED APPROX TWO MONTHS LATER, AND THE DOCTOR RE-EXPANDED THE CAGE AND ENGAGED THE LOCK SCREW. GLOBUS MEDICAL INC. WAS NOTIFIED OF THE COMPLAINT THREE DAYS LATER; HOWEVER, THE IMPLANT WAS NOT EXPANDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XPAND SPACER LARGE 25X32 4/4 39-41MME CORPECTOMY SPACER MQP GLOBUS MEDICAL, INC. 116.004 BGF325DK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention