BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAHA FLANGE FIXTURE AND ABUTMENT

    MDR report key: 4103384 · Received September 19, 2014

    Report

    Report Number
    6000034-2014-01325
    Event Type
    Injury
    Date Received
    September 19, 2014
    Report Date
    September 3, 2014
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    LXB
    PMA / PMN Number
    K955713
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583963 BAHA FLANGE FIXTURE AND ABUTMENT LXB: PRODUCT CODE LXB COCHLEAR BONE ANCHORED SOLUTIONS AB

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention