BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLANGE FIXTURE AND ABUTMENT

    MDR report key: 2860990 · Received December 6, 2012

    Report

    Report Number
    6000034-2012-02302
    Event Type
    Injury
    Date Received
    December 6, 2012
    Report Date
    April 19, 2013
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    LXB
    PMA / PMN Number
    K955713
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE CLINIC, THE PATIENT UNDERWENT SURGERY ON (B)(6) 2011 TO EXCISE AN OVERGROWTH OF SKIN TISSUE AROUND THE ABUTMENT. THIS REPORT IS FILED (B)(4) 2013. IMPLANTED DEVICE REMAINS.

    Additional Manufacturer Narrative · 1

    (B)(4): IMPLANTED DEVICE REMAINS.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT UNDERWENT TWO SURGERIES (DATES NOT REPORTED) TO EXCISE AN OVERGROWTH OF SKIN TISSUE AROUND THE ABUTMENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN RECEIVED AS OF THE DATE OF THIS REPORT, (B)(6), 2012.

    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