BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAHA FLANGE FIXTURE AND ABUTMENT

    MDR report key: 4121689 · Received September 26, 2014

    Report

    Report Number
    6000034-2014-01344
    Event Type
    Injury
    Date Received
    September 26, 2014
    Date of Event
    August 11, 2014
    Report Date
    September 4, 2014
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    LXB
    PMA / PMN Number
    K955713
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    IMPLANTED DEVICE REMAINS.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED SKIN FLAP ISSUES RESULTING IN DEVICE NON-USE. SUBSEQUENTLY, THE PATIENT UNDERWENT A SURGICAL PROCEDURE ON (B)(6), 2014 TO HAVE THE MAGNET REMOVED. THE IMPLANTED DEVICE REMAINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601641 BAHA FLANGE FIXTURE AND ABUTMENT LXB: PRODUCT CODE LXB COCHLEAR BONE ANCHORED SOLUTIONS AB 93530

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention