BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MESHGRAFT II COMPLETE

    MDR report key: 1960353 · Received December 16, 2010

    Report

    Report Number
    1526350-2010-00197
    Event Type
    Malfunction
    Date Received
    December 16, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 29, 2010
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    GFD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER; 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 REPORTED THAT THE ZIMMER MESHGRAFT II UNIT ROLLED THE SKIN UP AROUND THE ROLLER AND DID NOT MESH. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THE INCIDENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1