BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLANGE FIXTURE AND ABUTMENT

    MDR report key: 2914731 · Received January 14, 2013

    Report

    Report Number
    6000034-2013-00087
    Event Type
    Injury
    Date Received
    January 14, 2013
    Date of Event
    January 8, 2013
    Report Date
    May 3, 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
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT AVAILABLE FOR ANALYSIS. THIS REPORT IS FILED APRIL 28, 2014.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED DISCOMFORT WITH DEVICE USE DUE TO ITCHING SENSATION AROUND THE IMPLANT SIDE. THE PATIENT UNDERWENT REVISION SURGERY (DATE NOT REPORTED) TO RECEIVE A LONGER ABUTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21571 FLANGE FIXTURE AND ABUTMENT LXB LXB COCHLEAR BONE ANCHORED SOLUTIONS AB 93130

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention