BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLARIS 5.5 SYSTEM

    MDR report key: 2034014 · Received March 30, 2011

    Report

    Report Number
    2242816-2011-00027
    Event Type
    Malfunction
    Date Received
    March 30, 2011
    Date of Event
    March 2, 2011
    Report Date
    March 2, 2011
    Manufacturer
    EBI, LLC
    Product Code
    KWQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SHAFT OF THE FIXED SCREW BROKE. PATIENT OUTCOME: NO ADVERSE EFFECTS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLARIS 5.5 SYSTEM 5.5 X 40MM FIXED SCREW KWQ EBI, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1