BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLANGE FIXTURE AND ABUTMENT

    MDR report key: 5750291 · Received June 26, 2016

    Report

    Report Number
    6000034-2016-01233
    Event Type
    Injury
    Date Received
    June 26, 2016
    Report Date
    June 8, 2016
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    LXB
    PMA / PMN Number
    K100360
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE CLINIC, THE PATIENT WAS TREATED WITH A STERIOD INJECTION AT THE IMPLANT SITE (DATE NOT REPORTED). CORRECTION: THE CORRECT 510K # IS K100360, NOT K955713 AS INITIALLY REPORTED. (B)(4). IMPLANTED DEVICE REMAINS.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FILED JUNE 27, 2016. (B)(4). IMPLANTED DEVICE REMAINS.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT DEVELOPED AN INFECTION AT THE IMPLANT SITE AND WAS SUBSEQUENTLY TREATED WITH ORAL ANTIBIOTICS (DATE AND DURATION NOT REPORTED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404482 FLANGE FIXTURE AND ABUTMENT LXB LXB COCHLEAR BONE ANCHORED SOLUTIONS AB BI300 176317

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention