BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLANGE FIXTURE AND ABUTMENT

    MDR report key: 4180979 · Received October 17, 2014

    Report

    Report Number
    6000034-2014-01476
    Event Type
    Injury
    Date Received
    October 17, 2014
    Date of Event
    May 22, 2014
    Report Date
    September 25, 2014
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    LXB
    PMA / PMN Number
    K984162
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED SKIN OVERGROWTH ON THE ABUTMENT. SUBSEQUENTLY, THE PATIENT WAS ADMINISTERED GENERAL ANESTHESIA (B)(6) 2014, TO EXCISE THE EXCESS SKIN. THE IMPLANTED DEVICE REMAINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661577 FLANGE FIXTURE AND ABUTMENT LXB LXB COCHLEAR BONE ANCHORED SOLUTIONS AB N/A 76702

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Required Intervention