BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLANGE FIXTURE AND ABUTMENT

    MDR report key: 2924013 · Received January 22, 2013

    Report

    Report Number
    6000034-2013-00142
    Event Type
    Injury
    Date Received
    January 22, 2013
    Report Date
    January 16, 2013
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    LXB
    PMA / PMN Number
    K955713
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) IMPLANTED DEVICE REMAINS.

    Description of Event or Problem · 1

    PER PATIENT'S MOTHER, IT WAS REPORTED THAT THE PATIENT EXPERIENCED SKIN OVERGROWTH AND ERYTHEMA AROUND THE IMPLANT SITE. THE PATIENT WAS TREATED WITH TOPICAL ANTIBIOTICS (TYPE AND DATE NOT REPORTED) AND AMOXYCILLIN FOR A PERIOD OF TEN DAYS; HOWEVER, THE ISSUE COULD NOT BE RESOLVED. THE IMPLANTED DEVICE REMAINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30853 FLANGE FIXTURE AND ABUTMENT LXB, PRODUCT CODE: LXB LXB COCHLEAR BONE ANCHORED SOLUTIONS AB

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention