BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLANGE FIXTURE AND ABUTMENT

    MDR report key: 2052251 · Received April 12, 2011

    Report

    Report Number
    6000034-2011-00248
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    April 6, 2011
    Report Date
    May 6, 2011
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS
    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).

    Additional Manufacturer Narrative · 1

    (B)(6). THIS REPORT IS FILED (B)(4), 2011. IMPLANTED DEVICE REMAINS.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT DEVELOPED A KELOID SCAR OVER THE ABUTMENT. THE PATIENT WAS TREATED WITH STEROIDS. SURGERY WAS UNDERTAKEN TO REMOVE THE SCAR TISSUE ON (B)(4), 2011. THE IMPLANTED DEVICE REMAINS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Required Intervention