BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLANGE FIXTURE AND ABUTMENT

    MDR report key: 4975838 · Received August 6, 2015

    Report

    Report Number
    6000034-2015-01492
    Event Type
    Injury
    Date Received
    August 6, 2015
    Date of Event
    July 8, 2015
    Report Date
    August 10, 2015
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    LXB
    PMA / PMN Number
    K955713
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CURRENTLY NOT AVAILABLE FOR ANALYSIS.

    Additional Manufacturer Narrative · 1

    CORRECTION: THE CORRECT PMA NUMBER IS K955713, NOT K100360 AS PREVIOUSLY REPORTED. THIS REPORT IS FILED JANUARY 10, 2016. CURRENTLY UNAVAILABLE FOR ANALYSIS.

    Description of Event or Problem · 1

    PER THE CLINIC, THE FIXTURE AND ABUTMENT WERE EXPLANTED (DATE NOT REPORTED), DUE TO CHANGE IN HEARING PERFORMANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    519406 FLANGE FIXTURE AND ABUTMENT LXB, PRODUCT CODE: LXB COCHLEAR BONE ANCHORED SOLUTIONS AB

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention