BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLANGE FIXTURE AND ABUTMENT

    MDR report key: 2141790 · Received June 27, 2011

    Report

    Report Number
    6000034-2011-00454
    Event Type
    Injury
    Date Received
    June 27, 2011
    Report Date
    June 21, 2011
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    LXB
    PMA / PMN Number
    K955713
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PER THE CLINIC, THERE HAS BEEN SKIN OVERGROWTH ON THE ABUTMENT. ON SEVERAL OCCASIONS, THE PATIENT HAS REMOVED THE SKIN OVERGROWTH ON HER OWN WITHOUT SEEKING MEDICAL ATTENTION. 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 AB N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention