BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MESHGRAFT II DERMATOME WITH RATCHET

    MDR report key: 1900125 · Received October 22, 2010

    Report

    Report Number
    1526350-2010-00148
    Event Type
    Malfunction
    Date Received
    October 22, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 22, 2010
    Manufacturer
    ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS
    Product Code
    GFD
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 F/U MEDWATCH WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THERE WAS AN ACTUAL PT IMPLICATION WITH THIS MESHGRAFT AND IT WAS "NOT CATCHING SKIN". DETAILS OBTAINED DURING CLINICAL F/U, INDICATED THAT THE ZIMMER MESHGRAFT II WAS NOT PERFORATING SKIN EVEN WHEN STERILE GLOVE WRAPPER WAS PLACED UNDER CARRIER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1