BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATHFINDER NXT GENERIC

    MDR report key: 2945774 · Received January 6, 2013

    Report

    Report Number
    1649384-2012-00132
    Event Type
    Malfunction
    Date Received
    January 6, 2013
    Date of Event
    March 14, 2012
    Report Date
    December 7, 2012
    Manufacturer
    ZIMMER SPINE
    Product Code
    NKB
    PMA / PMN Number
    K100845
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE CONSTRUCT LOOSENED POST-OPERATIVELY. THE PT PRESENTED WITH RECURRENT PAIN AFTER SURGERY (TIMEFRAME UNSPECIFIED). X-RAYS SHOWED THE ROD HAD SLIPPED. NO FURTHER INFO WAS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6000 PATHFINDER NXT GENERIC PATHFINDER NXT GENERIC NKB ZIMMER SPINE 3500 PATHFINDER NXT UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR