BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MESHGRAFT II COMPLETE

    MDR report key: 3135037 · Received May 8, 2013

    Report

    Report Number
    1526350-2013-00230
    Event Type
    Malfunction
    Date Received
    May 8, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 8, 2013
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    FZW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR REPAIR AND EVALUATION. THE SERVICE RECORD INDICATES THAT THE DEVICE WAS MANUFACTURED ON 11/20/1989 AND WAS LAST REPAIRED ON (B)(6) 2012. EVALUATION OF THE DEVICE DETERMINED THAT THE REPORTED COMPLAINT COULD NOT BE DUPLICATED. PRIOR TO REPAIR, THE DEVICE WAS WITHIN CALIBRATION SPECIFICATIONS, AND THE DEVICE PRODUCED AN ACCEPTABLE TEST MESH. UNABLE TO DETERMINE A CAUSE OF THE REPORTED COMPLAINT. 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 CUTTING PROPERLY. ADDITIONAL CLINICAL FOLLOW UP WITH THE CUSTOMER INDICATED THAT THE MESHER WAS ONLY MESHING ON ONE SIDE OF THE DERMACARRIER. THE GRAFT WAS USEABLE AND THERE WAS NO PT INJURY, INCREASED SURGICAL TIME OR MEDICAL INTERVENTION. AN ADDITIONAL DEVICE WAS AVAILABLE ONSITE TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202649 MESHGRAFT II COMPLETE MESHGRAFT II COMPLETE FZW ZIMMER SURGICAL NA 10565

    Patients

    Seq Age Sex Outcome Treatment
    1