BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLANGE FIXTURE AND ABUTMENT

    MDR report key: 3033600 · Received April 3, 2013

    Report

    Report Number
    6000034-2013-00624
    Event Type
    Injury
    Date Received
    April 3, 2013
    Date of Event
    February 6, 2013
    Report Date
    April 8, 2013
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    LXB
    PMA / PMN Number
    K955713
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE CLINIC, THE PATIENT HAS PERMANENTLY DISCONTINUED USE OF THE DEVICE.THE IMPLANTED DEVICE REMAINS.THIS REPORT IS FILED (B)(4), 2013.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2013 TO REMOVE THE ABUTMENT AND EXCESS SKIN OVERGROWTH. IT IS UNKNOWN WHETHER THERE ARE PLANS TO REATTACH AN ABUTMENT AS OF THE DATE OF THIS REPORT,(B)(4) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136197 FLANGE FIXTURE AND ABUTMENT LXB LXB COCHLEAR BONE ANCHORED SOLUTIONS AB N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention