BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER SKING GRAFT MESHER

    MDR report key: 2915572 · Received January 10, 2013

    Report

    Report Number
    1526350-2013-00020
    Event Type
    Malfunction
    Date Received
    January 10, 2013
    Date of Event
    December 1, 2012
    Report Date
    December 13, 2012
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    FZW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 REPORTED THAT THE ZIMMER SKIN GRAFT MESHER WAS NOT WORKING PROPERLY. INITIAL OBSERVATION OF THE DEVICE RECEIVED BY THE MFR REVEALED A BENT COMB AND THAT THE DEVICE HAD BEEN MODIFIED FROM ITS ORIGINAL SPECS. NO ADD'L CLINICAL INFO WAS RECEIVED PRIOR TO THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14283 ZIMMER SKING GRAFT MESHER ZIMMER SKING GRAFT MESHER FZW ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1