BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLANGE FIXTURE AND ABUTMENT

    MDR report key: 3961930 · Received July 28, 2014

    Report

    Report Number
    6000034-2014-01025
    Event Type
    Injury
    Date Received
    July 28, 2014
    Date of Event
    September 11, 2012
    Report Date
    July 8, 2014
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    LXB
    PMA / PMN Number
    K955713
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 EXPERIENCED IRRITATION AT THE ABUTMENT SITE AND WAS PRESCRIBED ORAL ANTIBIOTICS. ON (B)(6), 2013 THE ABUTMENT SITE WAS DEBRIDED DUE TO INFECTION AND THE PATIENT WAS PRESCRIBED ORAL ANTIBIOTICS. THE SITE WAS DEBRIDED FOR A SECOND TIME DUE TO INFECTION IN (B)(6) 2014 (SPECIFIC DATE NOTE REPORTED). ON (B)(6), 2014, THE PATIENT WAS TAKEN TO THE OPERATING ROOM AND ADMINISTERED GENERAL ANESTHESIA TO FACILITATE AN ABUTMENT EXCHANGE. THE IMPLANTED DEVICE REMAINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438124 FLANGE FIXTURE AND ABUTMENT LXB, PRODUCT CODE: LXB LXB COCHLEAR BONE ANCHORED SOLUTIONS AB N/A 74543

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention