BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARRAY SPINE SYSTEM

    MDR report key: 689256 · Received March 15, 2006

    Report

    Report Number
    2242816-2006-00009
    Event Type
    Malfunction
    Date Received
    March 15, 2006
    Date of Event
    February 17, 2006
    Report Date
    March 14, 2006
    Manufacturer
    EBI,
    Product Code
    KWQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING ROUTINE 6 WEEK FOLLOW=UP VISIT MD NOTED ON X-RAY ROD HAD SLIPPED OUT OF SCREW. NUT WAS STILL IN PLACE. MD FEELD CONSTRUCT IS STABLE AND WILL LEAVE IN PLACE. IT SHOULD BEN OTED THE PT WAS PHYSICALLY ACTIVE DURING THE 6 WEEK TIME PERIOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARRAY SPINE SYSTEM INTERNAL SPINE FIXATION KWQ EBI, UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other