BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINALUSA

    MDR report key: 1883192 · Received October 20, 2010

    Report

    Report Number
    3005739886-2010-00004
    Event Type
    Malfunction
    Date Received
    October 20, 2010
    Date of Event
    September 20, 2010
    Report Date
    October 20, 2010
    Manufacturer
    SPINAL USA
    Product Code
    KWQ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    WHEN HOLDING THE INSERTER BOTH LATERAL POSTS DISENGAGED FROM THE INSERTER. SURGEON WAS ABLE TO LOCATE AND REMOVE THE POSTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPINALUSA ALIF BUTTRESS INSERTER KWQ SPINAL USA 22-9001 0026F

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention