BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESHGRAFT II COMPLETE

    MDR report key: 4212957 · Received October 24, 2014

    Report

    Report Number
    1526350-2014-00454
    Event Type
    Injury
    Date Received
    October 24, 2014
    Date of Event
    October 1, 2014
    Report Date
    October 1, 2014
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    FZW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MFR; HOWEVER, THE INVESTIGATION WAS NOT COMPLETED AT THE TIME OF THIS REPORT. A FOLLOW UP MEDWATCH WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE ZIMMER MESHGRAFT II COMPLETE NEEDED TO HAVE THE CUTTER REPLACED. ADDITIONAL CLINICAL INFO DETERMINED THAT THE REPORTED ISSUE OCCURRED DURING SURGERY. AS A RESULT OF THE ISSUE THE INITIAL SKIN GRAFT HARVEST WAS COMPLETELY DESTROYED AND AN ADDITIONAL UNPLANNED GRAFT HARVEST WAS REQUIRED TO BE TAKEN FROM THE PT. AN ALTERNATE DEVICE WAS RETRIEVED TO COMPLETE THE SURGERY, HOWEVER, THERE IS NO INFO REGARDING ANY DELAY THAT MAY HAVE OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678574 MESHGRAFT II COMPLETE MESHGRAFT II COMPLETE FZW ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1