BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAW BLADE

    MDR report key: 3803032 · Received May 5, 2014

    Report

    Report Number
    MW5035959
    Event Type
    Injury
    Date Received
    May 5, 2014
    Date of Event
    April 18, 2014
    Report Date
    May 2, 2014
    Manufacturer
    MAKO
    Product Code
    GFA
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    RETAINED FB S/P ROBOTIC ASSISTED LEFT TOTAL KNEE ARTHROPLASTY WITH COMPUTER NAVIGATION. SAW BLADE TOOTH BROKE OFF AND EMBEDDED IN SURGICAL WOUND. PT REQUIRED RETURN TO OPERATING ROOM FOR REMOVAL FOLLOWING DAY. REASON FOR USE: THIS PRODUCT, THE MAKO SAW BLADE WAS PART OF AN IDE TRIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268121 SAW BLADE SAW BLADE GFA MAKO

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention