BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XPAND SPACER SMALL 12X14 3.5/3.5 42-57MME

    MDR report key: 1133243 · Received August 14, 2008

    Report

    Report Number
    3004142400-2008-00009
    Event Type
    Injury
    Date Received
    August 14, 2008
    Date of Event
    July 15, 2008
    Report Date
    August 13, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPREHENSIVE INVESTIGATION WAS IMMEDIATELY INITIATED ON RECEIPT OF THE COMPLAINT AND PRODUCT. A REVIEW WAS CONDUCTED ON ALL APPLICABLE MATERIAL RECORDS, MANUFACTURING RECORDS, STORAGE RECORDS, AND DISTRIBUTION RECORDS. ALL RECORDS REVEALED THE PRODUCT WAS MANUFACTURED WITHIN SPECIFICATIONS, MAINTAINED AND DISTRIBUTED IN ACCORDANCE WITH ALL FEDERAL, STATE AND OPERATING PROCEDURES. THE SPACER WAS RETURNED FOR TEST AND EVALUATION. THE FIRST OBSERVATION IS THAT UPON RECEIPT, THE SET SCREW WAS NOT LOCKED. THERE WAS VISUAL DAMAGE TO THE IMPLANT (SCRATCHES) AND TO THE SET SCREW (FRAYING). ON EVALUATION, IT WAS DETERMINED THAT THE IMPLANT STILL FUNCTIONED PROPERLY AND THE SET SCREW TIGHTENS WHEN TURNED. BASED ON A RECORD REVIEW, TESTING, OBSERVATION, AND ALL AVAILABLE INFORMATION, IT IS DETERMINED THAT XPAND SPACER SMALL 12X14 3.5/3.5 42-57MME 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. ALL RECORDS PURPORT OF THE SPACER WAS OF THE HIGHEST QUALITY AND SAFETY.

    Description of Event or Problem · 1

    GLOBUS MEDICAL 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 AT LEVELS 3-6 OF THE CERVICAL SPINE (C3-C6). THE PATIENT WAS SCHEDULED TO UNDERGO ADDITIONAL SPINAL SURGERY AND RECEIVED A SUBSEQUENT MRI. IT WAS REPORTED THAT THE MRI IDENTIFIED THE PRODUCT AS "APPEARED TO COLLAPSE." THE PRODUCT WAS REMOVED THE FOLLOWING MONTH, DURING THE SUBSEQUENTLY SCHEDULED SPINAL SURGERY. GLOBUS MEDICAL WAS NOTIFIED OF THE COMPLAINT AND RECEIVED THE COLLAPSED SPACER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XPAND SPACER SMALL 12X14 3.5/3.5 42-57MME CORPECTOMY SPACER MQP GLOBUS MEDICAL, INC. 116.111 BGH178EJ

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention