BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLANGE FIXTURE AND ABUTMENT

    MDR report key: 3211178 · Received July 8, 2013

    Report

    Report Number
    6000034-2013-01251
    Event Type
    Injury
    Date Received
    July 8, 2013
    Report Date
    June 24, 2013
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    LXB
    PMA / PMN Number
    K955713
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE NOT AVAILABLE FOR ANALYSIS.

    Description of Event or Problem · 1

    PER A JOURNAL ARTICLE, IN LARYNGOLOGY AND OTOLARYNGOLOGY PUBLISHED, MAY 30, 2013 (PAGES 1-7); IT WAS REPORTED THAT THERE HAVE BEEN SEVEN CASES OF SKIN OVERGROWTH, ALL OF WHICH HAVE BEEN MANAGED SURGICALLY. IT WAS ALSO REPORTED THAT THERE HAVE BEEN THREE CASES OF LOSS OF OSSEOINTEGRATION THAT HAVE RESULTED IN FIXTURE LOSS. PATIENT INFORMATION WAS NOT IDENTIFIED IN THE JOURNAL ARTICLE. ATTEMPTS TO OBTAIN PATIENT INFORMATION HAVE BEEN UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309622 FLANGE FIXTURE AND ABUTMENT LXB, PRODUCT CODE: LXB LXB COCHLEAR BONE ANCHORED SOLUTIONS AB

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention