BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLANGE FIXTURE AND ABUTMENT

    MDR report key: 3241322 · Received July 22, 2013

    Report

    Report Number
    6000034-2013-01356
    Event Type
    Injury
    Date Received
    July 22, 2013
    Date of Event
    July 3, 2013
    Report Date
    July 19, 2013
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    LXB
    PMA / PMN Number
    K955713
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IMPLANTED DEVICE REMAINS.

    Description of Event or Problem · 1

    PER THE CLINIC, ON (B)(6) 2012, THE PATIENT REPORTED CLEAR DRAINAGE AND INFLAMMATION AROUND THE ABUTMENT SITE. THE PATIENT WAS PRESCRIBED AUGMENTIN (DOSAGE NOT REPORTED) ALTHOUGH NO INFECTION WAS IDENTIFIED. ON (B)(6) 2013, INFLAMMATION WAS OBSERVED AT THE IMPLANT SITE, AND THE PATIENT WAS PRESCRIBED A SECOND COURSE OF ANTIBIOTICS (TYPE AND DOSAGE NOT REPORTED.) THE IMPLANTED DEVICE REMAINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341824 FLANGE FIXTURE AND ABUTMENT LXB LXB COCHLEAR BONE ANCHORED SOLUTIONS AB 90432

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention