BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLANGE FIXTURE AND ABUTMENT

    MDR report key: 3013689 · Received March 20, 2013

    Report

    Report Number
    6000034-2013-00516
    Event Type
    Injury
    Date Received
    March 20, 2013
    Date of Event
    March 8, 2013
    Report Date
    March 11, 2013
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    LXB
    PMA / PMN Number
    K955713
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): IMPLANTED DEVICE REMAINS.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED A LACK OF AUDITORY BENEFIT WITH DEVICE USE. THE PATIENT UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2013 TO HAVE THE ABUTMENT REMOVED. THE PATIENT WAS ADMINISTERED IV ANTIBIOTICS (TYPE AND AMOUNT UNKNOWN) DURING THE PROCEDURE. THERE ARE NO PLANS TO REATTACH AN ABUTMENT IN THE FIXTURE. THE IMPLANTED DEVICE REMAINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115188 FLANGE FIXTURE AND ABUTMENT LXB, PRODUCT CODE: LXB LXB COCHLEAR BONE ANCHORED SOLUTIONS AB

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention