BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLANGE FIXTURE AND ABUTMENT

    MDR report key: 3914317 · Received July 3, 2014

    Report

    Report Number
    6000034-2014-00917
    Event Type
    Injury
    Date Received
    July 3, 2014
    Date of Event
    February 17, 2014
    Report Date
    June 11, 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). IMPLANTED DEVICE REMAINS.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED SKIN OVERGROWTH AT THE ABUTMENT SITE. SUBSEQUENTLY, THE PATIENT UNDERWENT A PROCEDURE ON (B)(6) 2014, TO EXCISE THE EXCESS SKIN AND WAS PRESCRIBED ORAL ANTIBIOTICS (DURATION NOT REPORTED). THE IMPLANTED DEVICE REMAINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389539 FLANGE FIXTURE AND ABUTMENT LXB, PRODUCT CODE LXB COCHLEAR BONE ANCHORED SOLUTIONS AB 90672

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Required Intervention