BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLANGE FIXTURE AND ABUTMENT

    MDR report key: 2183329 · Received July 28, 2011

    Report

    Report Number
    6000034-2011-00546
    Event Type
    Injury
    Date Received
    July 28, 2011
    Date of Event
    July 20, 2011
    Report Date
    July 20, 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). IMPLANTED DEVICE REMAINS.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT UNDERWENT A PROCEDURE ON (B)(6) 2011 TO REMOVE SKIN OVERGROWTH FROM THE ABUTMENT. 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 10 YR Required Intervention