BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARRAY SPINAL SYSTEM

    MDR report key: 1344587 · Received January 19, 2009

    Report

    Report Number
    2242816-2008-00158
    Event Type
    Malfunction
    Date Received
    January 19, 2009
    Date of Event
    January 10, 2008
    Report Date
    December 17, 2008
    Manufacturer
    EBI, LLC
    Product Code
    MNI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL COMPONENTS ASSOCIATED WITH THE EVENT ARE AS FOLLOWS: CATALOG NO.: 94640, SCREW, QTY.= 2; 94735, SCREW, QTY. = 1; 94039, ROD, QTY. = 2; 94000, SET SCREW, QTY. = 4.

    Description of Event or Problem · 1

    THE PEDICLE SCREW BROKE AND WAS SURGICALLY REMOVED. PT OUTCOME: THE PT WAS IN GOOD CONDITION AT THE CONCLUSION OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARRAY SPINAL SYSTEM MNI EBI, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR