BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLANGE FIXTURE AND ABUTMENT

    MDR report key: 4140829 · Received October 3, 2014

    Report

    Report Number
    6000034-2014-01353
    Event Type
    Injury
    Date Received
    October 3, 2014
    Report Date
    September 15, 2014
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    LXB
    PMA / PMN Number
    K955713
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE IMPLANTED DEVICE REMAINS.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT WAS PRESCRIBED ORAL ANTIBIOTICS (DATE NOT REPORTED) DUE TO AN INFECTION AT THE ABUTMENT SITE. THE IMPLANTED DEVICE REMAINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620221 FLANGE FIXTURE AND ABUTMENT LXB LXB COCHLEAR BONE ANCHORED SOLUTIONS AB N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention