BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLANGE FIXTURE AND ABUTMENT

    MDR report key: 2731156 · Received September 6, 2012

    Report

    Report Number
    6000034-2012-01721
    Event Type
    Injury
    Date Received
    September 6, 2012
    Date of Event
    August 24, 2012
    Report Date
    December 2, 2013
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    LXB
    PMA / PMN Number
    K984162
    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.

    Additional Manufacturer Narrative · 1

    (B)(6). CORRECTION: THE CORRECT PART NUMBER IS 92135; NOT 92127 AS PREVIOUSLY REPORTED. CORRECTION: THE CORRECT PMA # IS K984162; NOT K955713 AS PREVIOUSLY REPORTED. THIS REPORT IS FILED APRIL 2, 2014. IMPLANTED DEVICE REMAINS.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2012, TO EXCISE AN OVERGROWTH OF SKIN TISSUE AROUND THE IMPLANT SITE. A SKIN GRAFT WAS ALSO TAKEN FROM THE ANTERIOR PORTION OF THE PATIENT'S LEG. 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 11 YR Required Intervention