BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAHA FLANGE FIXTURE AND ABUTMENT

    MDR report key: 4203808 · Received October 27, 2014

    Report

    Report Number
    6000034-2014-01521
    Event Type
    Injury
    Date Received
    October 27, 2014
    Report Date
    October 13, 2014
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    LXB
    PMA / PMN Number
    K984162
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS CURRENTLY UNAVAILABLE.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED A LOSS OF OSSEOINTEGRATION (DATE NOT REPORTED) RESULTING IN FIXTURE LOSS. THE DEVICE HAS NOT BEEN MADE AVAILABLE FOR ANALYSIS AS OF THE DATE OF THIS REPORT, (B)(4) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683587 BAHA FLANGE FIXTURE AND ABUTMENT LXB: PRODUCT CODE LXB COCHLEAR BONE ANCHORED SOLUTIONS AB 86148

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention