BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLANGE FIXTURE AND ABUTMENT

    MDR report key: 3241424 · Received July 22, 2013

    Report

    Report Number
    6000034-2013-01358
    Event Type
    Injury
    Date Received
    July 22, 2013
    Date of Event
    December 12, 2012
    Report Date
    July 19, 2013
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    LXB
    PMA / PMN Number
    K984162
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IMPLANTED DEVICE REMAINS.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT DEVELOPED AN INFECTION, SWELLING AND BLEEDING AT THE IMPLANT SITE. THE PATIENT WAS SEEN IN THE CLINIC AND THE AREA WAS DEBRIDED AND TREATED WITH GENTIAN VIOLET. THE IMPLANTED DEVICE REMAINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340661 FLANGE FIXTURE AND ABUTMENT LXB LXB COCHLEAR BONE ANCHORED SOLUTIONS AB 92126

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Required Intervention