BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLANGE FIXTURE AND ABUTMENT

    MDR report key: 3973482 · Received August 1, 2014

    Report

    Report Number
    6000034-2014-01104
    Event Type
    Injury
    Date Received
    August 1, 2014
    Date of Event
    December 10, 2012
    Report Date
    July 14, 2014
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    LXB
    PMA / PMN Number
    K955713
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE IMPLANTED DEVICE REMAINS.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT WAS TAKEN TO THE OPERATING ROOM AND ADMINISTERED GENERAL ANESTHESIA ON (B)(6) 2012 FOR SKIN REVISION DUE TO SKIN OVERGROWTH; DURING THE SAME SURGERY, A LONGER ABUTMENT WAS PLACED. THE IMPLANTED DEVICE REMAINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450751 FLANGE FIXTURE AND ABUTMENT LXB, PRODUCT CODE: LXB LXB COCHLEAR BONE ANCHORED SOLUTIONS AB N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention