BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLANGE FIXTURE AND ABUTMENT

    MDR report key: 2883990 · Received December 21, 2012

    Report

    Report Number
    6000034-2012-02382
    Event Type
    Injury
    Date Received
    December 21, 2012
    Report Date
    April 22, 2013
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    LXB
    PMA / PMN Number
    K955713
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CORRECTION: THE CORRECT CATALOG NUMBER IS 90434; NOT 92133 AS PREVIOUSLY REPORTED. THIS REPORT IS FILED (B)(4) 2013.

    Additional Manufacturer Narrative · 1

    PER THE PATIENT'S SURGEON, THE PATIENT WAS REIMPLANTED WITH A NEW DEVICE (B)(6), 2012.THIS REPORT IS FILED (B)(4), 2013.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED A LOSS OF OSSEOINTEGRATION (DATE NOT REPORTED) RESULTING IN FIXTURE LOSS. THERE ARE PLANS TO REIMPLANT THE PATIENT WITH ANOTHER DEVICE, BUT IT IS UNKNOWN IF THIS HAS OCCURRED AS OF THE DATE OF THIS REPORT, (B)(6) 2012.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention