BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLANGE FIXTURE AND ABUTMENT

    MDR report key: 2801861 · Received October 23, 2012

    Report

    Report Number
    6000034-2012-02017
    Event Type
    Injury
    Date Received
    October 23, 2012
    Report Date
    January 11, 2013
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    LXB
    PMA / PMN Number
    K955713
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE PATIENT'S SURGEON, THE DEVICE WAS EXPLANTED ON (B)(6) 2012. THERE ARE NO PLANS OF REIMPLANTION AS OF THE DATE OF THIS REPORT. THIS REPORT IS FILED (B)(4) 2012.

    Additional Manufacturer Narrative · 1

    (B)(4). IMPLANTED DEVICE REMAINS.

    Additional Manufacturer Narrative · 1

    CORRECTION: THE CORRECT CATALOG NUMBER IS 90432; NOT 92127 AS PREVIOUSLY REPORTED. THIS REPORT IS FILED (B)(4) 2013.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED SCALP PAIN AND IMPAIRED HEALING AROUND THE IMPLANT SITE. THE PATIENT WAS TREATED WITH MARCAINE INJECTIONS (DATE NOT REPORTED) AND THE ABUTMENT WAS REMOVED, BUT THE ISSUE COULD NOT BE RESOLVED. THE IMPLANTED DEVICE REMAINS. THERE ARE NO PLANS TO EXPLANT THE DEVICE 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, PRODCUT CODE: LXB LXB COCHLEAR BONE ANCHORED SOLUTIONS AB N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention