BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLANGE FIXTURE AND ABUTMENT

    MDR report key: 5998926 · Received October 4, 2016

    Report

    Report Number
    6000034-2016-01915
    Event Type
    Injury
    Date Received
    October 4, 2016
    Report Date
    September 13, 2016
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    LXB
    PMA / PMN Number
    K955713
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE AND INITIAL IMPLANTATION DETAILS UNAVAILABLE AT THE TIME OF THIS REPORT OCTOBER 05, 2016. REGISTRATION NUMBER 3009092818 EXEMPTION NUMBER E2016011. THIS REPORT IS FILED ON OCTOBER 05, 2016. H3 OTHER TEXT : IMPLANTED DEVICE REMAINS.

    Description of Event or Problem · 0

    PER THE CLINIC, PATIENT DEVELOPED AN INFECTION AT ABUTMENT SITE. CLINICAL MANAGEMENT IS ONGOING. THE IMPLANTED DEVICE REMAINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    647125 FLANGE FIXTURE AND ABUTMENT LXB LXB COCHLEAR BONE ANCHORED SOLUTIONS AB N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention