BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESHGRAFT II DERMATOME WITH RATCHET

    MDR report key: 2172574 · Received July 20, 2011

    Report

    Report Number
    1526350-2011-00154
    Event Type
    Injury
    Date Received
    July 20, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 23, 2011
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    GFD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR REPAIR. THE SERVICE RECORDS INDICATE THAT THE DEVICE IS 4 YEARS OLD AND HAS BEEN RETURNED FOR REPAIR PREVIOUSLY. THE INSPECTION FOUND THAT THE DEVICE WAS SLIGHTLY OUT OF CALIBRATION. THE INVESTIGATION WAS UNABLE TO DETERMINE A CAUSE OF THE REPORTED COMPLAINT. THE DEVICE BEING SLIGHTLY OUT OF CALIBRATION WOULD NOT HAVE CAUSED 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 CUTTING INTO STRIPS. ADDITIONAL CLINICAL FOLLOW UP WITH THE HOSPITAL INDICATED THAT THE SKIN GRAFT TURNED INTO TINY STRIPS AND AGREED THAT 'LIKE SPAGHETTI." AN ADDITIONAL GRAFT NEEDED TO BE HARVESTED TO COMPLETE THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MESHGRAFT II DERMATOME WITH RATCHET MESHGRAFT II DERMATOME WITH RATCHET GFD ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1