BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLANGE FIXTURE AND ABUTMENT

    MDR report key: 3233675 · Received July 18, 2013

    Report

    Report Number
    6000034-2013-01315
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    September 7, 2013
    Report Date
    September 7, 2013
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    LXB
    PMA / PMN Number
    K955713
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT WAS PLACED UNDER GENERAL ANESTHESIA (DATE NOT REPORTED) TO EXCHANGE THE ABUTMENT DUE TO SKIN GROWTH ON THE ABUTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336044 FLANGE FIXTURE AND ABUTMENT LXB LXB COCHLEAR BONE ANCHORED SOLUTIONS AB

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Required Intervention