BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLANGE FIXTURE AND ABUTMENT

    MDR report key: 1060894 · Received June 13, 2008

    Report

    Report Number
    6000034-2008-00328
    Event Type
    Injury
    Date Received
    June 13, 2008
    Date of Event
    May 19, 2008
    Report Date
    June 16, 2008
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS, AB
    Product Code
    LXB
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A FINAL REPORT. THE TYPE OF EVENT IS ADDRESSED IN THE DEVICE LABELING.

    Description of Event or Problem · 1

    PER THE AUDIOLOGIST, IN 2008, TH PT'S FIXTURE FELL OUT AFTER SELF-REMOVING THE HEALING CAP. REPORTEDLY, THE REPLACEMENT FIXTURE WILL BE PLACED IN A DIFFERENT LOCATION AND PLACING A "SLEEPER' FIXTURE WAS DISCUSSED WITH THE PT. A REVISION SURGERY IS SCHEDULED, AFTER THE SITE HEALS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLANGE FIXTURE AND ABUTMENT BONE-ANCHORED IMPLANT LXB COCHLEAR BONE ANCHORED SOLUTIONS, AB 90434 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention