BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLANGE FIXTURE AND ABUTMENT

    MDR report key: 3963831 · Received July 29, 2014

    Report

    Report Number
    6000034-2014-01133
    Event Type
    Injury
    Date Received
    July 29, 2014
    Date of Event
    June 24, 2014
    Report Date
    July 25, 2014
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    LXB
    PMA / PMN Number
    K955713
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT UNDERWENT REVISION SURGERY TO EXCISE THE EXCESS SKIN ON (B)(6), 2014 DUE TO SKIN OVERGROWTH. THE IMPLANTED DEVICE REMAINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441530 FLANGE FIXTURE AND ABUTMENT LXB, PRODUCT CODE: LXB LXB COCHLEAR BONE ANCHORED SOLUTIONS AB N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Required Intervention