BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AZURE ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 3633621 · Received October 31, 2013

    Report

    Report Number
    3008524126-2013-00023
    Event Type
    Malfunction
    Date Received
    October 31, 2013
    Date of Event
    October 24, 2013
    Report Date
    October 31, 2013
    Manufacturer
    ORTHOFIX INC.
    Product Code
    KWQ
    PMA / PMN Number
    K130825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    BASED ON THE INFO PROVIDED, THE MOST SUPERIOR BONE SCREW IS BACKING OUT OF THE 86-0354 PLATE. X-RAY SHOWED FRAGMENT DIRECTLY ABOVE BONE SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    561941 AZURE ANTERIOR CERVICAL PLATE SYSTEM 3 LEVEL STANDARD PLATE, 54MM KWQ ORTHOFIX INC. 86-0354 K23

    Patients

    Seq Age Sex Outcome Treatment
    1 Other