BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLANGE FIXTURE AND ABUTMENT

    MDR report key: 3821340 · Received May 20, 2014

    Report

    Report Number
    6000034-2014-00796
    Event Type
    Injury
    Date Received
    May 20, 2014
    Report Date
    May 16, 2014
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    LXB
    PMA / PMN Number
    K955713
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE IS UNAVAILABLE FOR ANALYSIS.

    Description of Event or Problem · 1

    PER THE SURGEON, THE PATIENT EXPERIENCED A LOSS OF OSSEOINTEGRATION (DATE NOT REPORTED) RESULTING IN FIXTURE LOSS. ON (B)(6) 2014 THE SURGEON MADE AN INCISION TO ACCESS THE SLEEPER FIXTURE. THE DEVICE IS UNAVAILABLE FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300175 FLANGE FIXTURE AND ABUTMENT LXB, PRODUCT CODE: LXB LXB COCHLEAR BONE ANCHORED SOLUTIONS AB N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention