BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLUE RIDGE

    MDR report key: 2800999 · Received October 18, 2012

    Report

    Report Number
    3004774118-2012-00022
    Event Type
    Injury
    Date Received
    October 18, 2012
    Date of Event
    October 4, 2012
    Report Date
    October 17, 2012
    Manufacturer
    K2M, INC.
    Product Code
    KWQ
    PMA / PMN Number
    K113329
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THOUGH NO INJURY TO THE PT HAS BEEN REPORTED, THE INCIDENT IS BEING REPORTED AS A PRECAUTION BASED ON EXPERT OPINION FROM OUR MEDICAL DIRECTOR THAT THERE COULD BE THE POTENTIAL FOR AN INJURY TO THE ESOPHAGUS.

    Description of Event or Problem · 1

    BOTTOM TWO SCREWS HAVE BACKED OUT OF A TWO-LEVEL BLUE RIDGE PLATE APPROX SIX MONTHS POST-OPERATIVELY. THE PT IS BEING MONITORED BY THE SURGEON AND HAS NOT BEEN REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLUE RIDGE CERVICAL PLATE KWQ K2M, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other