BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLANGE FIXTURE AND ABUTMENT

    MDR report key: 2942633 · Received February 4, 2013

    Report

    Report Number
    6000034-2013-00161
    Event Type
    Injury
    Date Received
    February 4, 2013
    Report Date
    January 22, 2013
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    LXB
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FIXTURE IS NOT AVAILABLE FOR ANALYSIS.THIS REPORT IS FILED AUGUST 29, 2013.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED POOR PERFORMANCE WITH THE DEVICE. REPROGRAMMING ATTEMPTS WERE MADE; HOWEVER, THE ISSUE COULD NOT BE RESOLVED. THE PATIENT UNDERWENT A PROCEDURE (DATE NOT REPORTED) TO HAVE THE ABUTMENT REMOVED AND A SLEEPER CAP WAS PLACED. DURING THE SAME PROCEDURE, THE PATIENT WAS IMPLANTED WITH A NEW FIXTURE/ABUTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46728 FLANGE FIXTURE AND ABUTMENT PRODUCT CODE: LXB LXB COCHLEAR BONE ANCHORED SOLUTIONS AB

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention