BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NATURAL-KNEE SYSTEM HTO BONE FIXATION PLATE

    MDR report key: 2193426 · Received July 13, 2011

    Report

    Report Number
    1822565-2011-01627
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Date of Event
    June 16, 2011
    Report Date
    June 16, 2011
    Manufacturer
    ZIMMER INC
    Product Code
    HRS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT DURING SURGERY, WHEN THE USER PUT THE PLATE IN PLACE, HE REALIZED THAT THE PLATE WAS A NON-STERILE PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NATURAL-KNEE SYSTEM HTO BONE FIXATION PLATE TRAUMA PROSTHESIS HRS ZIMMER INC 2592423

    Patients

    Seq Age Sex Outcome Treatment
    1