BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 6371077 · Received March 1, 2017

    Report

    Report Number
    6000034-2017-00480
    Event Type
    Injury
    Date Received
    March 1, 2017
    Report Date
    February 23, 2017
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    LXB
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED A LOSS OF OSSEOINTEGRATION RESULTING IN FIXTURE LOSS. THERE ARE PLANS TO PLACE AN ABUTMENT ON THE SLEEPER IMPLANT, HOWEVER; IT IS UNKNOWN IF THIS HAS OCCURRED AS OF THE DATE OF THIS REPORT MARCH 02, 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150691 UNKNOWN COCHLEAR BAHA CONNECT SYSTEM LXB COCHLEAR BONE ANCHORED SOLUTIONS AB UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention