BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATHFINDER/DDS GENERIC

    MDR report key: 2512438 · Received March 28, 2012

    Report

    Report Number
    1649384-2012-00033
    Event Type
    Malfunction
    Date Received
    March 28, 2012
    Date of Event
    February 27, 2012
    Report Date
    February 27, 2012
    Manufacturer
    ZIMMER SPING
    Product Code
    GFC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. THE BATCH NUMBER IS UNK AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. THIS IS THE FINAL REPORT THAT WILL BE SUBMITTED ASSOCIATED WITH THIS INCIDENT AND DEVICE. NO ADDITIONAL ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO PATHFINDER SCREWS WERE REMOVED FROM THE PT DUE TO BEING LOOSE. NO FURTHER INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PATHFINDER/DDS GENERIC PATHFINDER/DSS GENERIC GFC ZIMMER SPING 1100 PATHFINDER-DSS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1