BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MESHGRAFT II COMPLETE

    MDR report key: 2776642 · Received October 3, 2012

    Report

    Report Number
    1526350-2012-00243
    Event Type
    Malfunction
    Date Received
    October 3, 2012
    Date of Event
    September 1, 2012
    Report Date
    September 6, 2012
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    FXQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR REPAIR AND EVALUATION. THE SERVICE RECORD INDICATES THAT THE DEVICE IS 18 YEARS OLD AND WAS LAST RETURNED TO THE MANUFACTURER FOR REPAIR ON (B)(4) 1997. INSPECTION OF THE DEVICE DISPLAYED A DAMAGED ROLLER AND CUTTER. PRIOR TO REPAIR, UNIT WAS IN CALIBRATION. DAMAGE TO THESE COMPONENTS COULD HAVE CAUSED THE CUSTOMER¿S EVENT. THE CAUSE IS MOST LIKELY DUE TO THE USER NOT MAINTAINING THE DEVICE PER PREVENTIVE MAINTENANCE AND HANDLING ACCORDING TO THE INSTRUCTIONS FOR USE. THE MESHGRAFT II TISSUE EXPANSION SYSTEM SHOULD BE RETURNED EVERY 12 MONTHS FOR INSPECTION AND PREVENTIVE MAINTENANCE. ANNUAL FACTORY CALIBRATION CHECKS ARE STRONGLY RECOMMENDED TO VERIFY CONTINUED ACCURACY. THE DEVICE WAS SERVICED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ZIMMER MESHGRAFT II WAS NOT MESHING UNIFORMLY. ADDITIONAL CLINICAL FOLLOW UP WITH THE HOSPITAL INDICATED THAT THE GRAFT WAS ¿PARTIALLY MESHED¿. THE INITIAL GRAFT WAS USED AND THERE WAS NO REPORT OF ADDITIONAL HARVEST, INCREASED SURGICAL TIME, OR MEDICAL INTERVENTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1