BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORMULA AGGRESSIVE PLUS

    MDR report key: 2013173 · Received February 28, 2011

    Report

    Report Number
    2013173
    Event Type
    Malfunction
    Date Received
    February 28, 2011
    Date of Event
    February 10, 2010
    Report Date
    February 28, 2011
    Manufacturer
    ASCENT HEALTHCARE SOLUTIONS
    Product Code
    HRX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US

    Narratives

    Description of Event or Problem · 1

    DURING KNEE ARTHROSCOPY, A POSSIBLE TOOTH FROM THE SHAVER WAS MISSING FROM THE SHAVER AT THE END OF THE PROCEDURE. THE SURGEON WAS NOTIFIED AND AN X-RAY WAS TAKEN. NO EVIDENCE OF THE TOOTH IN THE KNEE WAS OBSERVED ON THE X-RAY. THE SHAVER WAS A RE-PROCESSED PIECE OF EQUIPMENT BY ASCENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FORMULA AGGRESSIVE PLUS ARTHROSCOPE, SHAVER, STRYKER HRX ASCENT HEALTHCARE SOLUTIONS 375-544-000 1360407

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR