BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLANGE FIXTURE AND ABUTMENT

    MDR report key: 3162448 · Received June 11, 2013

    Report

    Report Number
    6000034-2013-01038
    Event Type
    Injury
    Date Received
    June 11, 2013
    Report Date
    May 28, 2013
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    LXB
    PMA / PMN Number
    K955713
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): IMPLANTED DEVICE REMAINS.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT DEVELOPED AN INFECTION AT THE IMPLANT SITE. THE PATIENT IS CURRENTLY BEING TREATED WITH ORAL ANTIBIOTICS (TYPE AND AMOUNT NOT REPORTED) AS WELL AS TOPICAL STEROIDS AND BACTROBAN. THE IMPLANTED DEVICE REMAINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263002 FLANGE FIXTURE AND ABUTMENT LXB, PRODUCT CODE: LXB LXB COCHLEAR BONE ANCHORED SOLUTIONS AB 93330 131261

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention