BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MESHGRAFT II COMPLETE

    MDR report key: 1781108 · Received July 29, 2010

    Report

    Report Number
    1526350-2010-00077
    Event Type
    Malfunction
    Date Received
    July 29, 2010
    Date of Event
    July 1, 2010
    Report Date
    July 9, 2010
    Manufacturer
    ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS
    Product Code
    FZW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MFR AT THE TIME OF THIS REPORT. A FOLLOW UP MEDWATCH WILL BE SUBMITTED ONCE THE DEVICE HAS BEEN RETURNED AND THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ZIMMER MESHGRAFT II DID NOT MESH COMPLETELY. ADDITIONAL INFO RECEIVED STATED THAT THERE WAS NO PT HARM OR INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1