BEUDAMED
    FDA Adverse Event Summary report: N

    GLOBUS MEDICAL, INC.

    MDR report key: 4059320 · Received August 27, 2014

    Report

    Report Number
    MW5038026
    Date Received
    August 27, 2014
    Date of Event
    May 7, 2014
    Report Date
    August 14, 2014
    Manufacturer
    GLOBUS MEDICAL, INC.
    Product Code
    OVE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    FAILED C4 TO C7 RIGHT EXPANDABLE INTERBODY CAGE DEVICE WITH BREAKOUT OF ANTERIOR PLATE SCREWS. PT HAD A TWO LEVEL CORPECTOMY FOR CORD AND ROOT COMPRESSION ON (B)(6) 2014. EXPANDABLE CAGE COLLAPSED DOWN AFTER THE PT WAS DISCHARGED DISLODGING THE C4-C7 PLATE AND DAMAGING THE C4 VERTEBRAL BODY, EXPELLING THE C4 SCREWS. GLOBUS SPINE REP WERE PRESENT DURING THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522463 GLOBUS MEDICAL, INC. EXPANDABLE TITANIUM CAGE W/ ANTERIOR CERVICAL PLATING OVE GLOBUS MEDICAL, INC.
    522464 GOLBUS MEDICAL, INC. EXPANDABLE TITANIUM CAGE W/ ANTERIOR CERVICAL PLATING KWP GLOBUS MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention