BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLANGE FIXTURE AND ABUTMENT

    MDR report key: 3266390 · Received August 6, 2013

    Report

    Report Number
    6000034-2013-01439
    Event Type
    Injury
    Date Received
    August 6, 2013
    Report Date
    August 19, 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

    PER THE SURGEON, THE PATIENT WAS REIMPLANTED WITH A NEW FIXTURE/ABUTMENT ON (B)(6) 2013. CORRECTION: THE CORRECT CATALOG NUMBER IS 90434; NOT 93330 AS PREVIOUSLY REPORTED. THIS REPORT IS FILED OCTOBER 23, 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 REPLACE THE LOST FIXTURE, BUT IT IS UNKNOWN IF THIS HAS OCCURRED AS OF THE DATE OF THIS REPORT, (B)(4) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367588 FLANGE FIXTURE AND ABUTMENT LXB LXB COCHLEAR BONE ANCHORED SOLUTIONS AB N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention