BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLANGE FIXTURE AND ABUTMENT

    MDR report key: 3831318 · Received May 24, 2014

    Report

    Report Number
    6000034-2014-00763
    Event Type
    Injury
    Date Received
    May 24, 2014
    Report Date
    May 12, 2014
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    LXB
    PMA / PMN Number
    K955713
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, 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 AT THE IMPLANT SITE. THE PATIENT WAS TREATED WITH ORAL ANTIBIOTICS (DATE NOT REPORTED). THE IMPLANTED DEVICE REMAINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309623 FLANGE FIXTURE AND ABUTMENT LXB, PRODUCT CODE LXB COCHLEAR BONE ANCHORED SOLUTIONS AB

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention