BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLANGE FIXTURE AND ABUTMENT

    MDR report key: 3013609 · Received March 20, 2013

    Report

    Report Number
    6000034-2013-00550
    Event Type
    Injury
    Date Received
    March 20, 2013
    Date of Event
    February 5, 2013
    Report Date
    February 5, 2013
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    LXB
    PMA / PMN Number
    K955713
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IMPLANTED DEVICE REMAINS.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED TENDERNESS AROUND THE IMPLANT SITE, AND THE ISSUE COULD NOT BE RESOLVED. THE PATIENT WAS ADMINISTERED LOCAL ANESTHETIC ON (B)(6) 2013, TO FACILITATE REMOVAL OF THE ABUTMENT AND PLACEMENT OF A COVER SCREW. THE IMPLANTED DEVICE REMAINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115505 FLANGE FIXTURE AND ABUTMENT LXB LXB COCHLEAR BONE ANCHORED SOLUTIONS AB N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention