BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLANGE FIXTURE AND ABUTMENT

    MDR report key: 3040837 · Received April 8, 2013

    Report

    Report Number
    6000034-2013-00621
    Event Type
    Injury
    Date Received
    April 8, 2013
    Report Date
    March 28, 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
    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 AROUND THE IMPLANT SITE WHICH WAS TREATED WITH KEFLEX (DATE NOT REPORTED.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144211 FLANGE FIXTURE AND ABUTMENT LXB LXB COCHLEAR BONE ANCHORED SOLUTIONS AB 92127

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention