BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCUTANEOUS REFERENCE CROSS PIN FRAME

    MDR report key: 8545488 · Received April 24, 2019

    Report

    Report Number
    1723170-2019-01957
    Event Type
    Malfunction
    Date Received
    April 24, 2019
    Date of Event
    April 10, 2019
    Report Date
    April 24, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    MAX
    PMA / PMN Number
    K131425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT INFORMATION PROVIDED AS NO PATIENT WAS INVOLVED IN THIS CONCERN. THE FRAME, 9732353, PERC REF, CROSS PIN (180118) WAS RETURNED FOR ANALYSIS. UPON RETURN ANALYSIS FOUND THAT THE PIVOT TENSION HAD BEEN RELEASED. AFTER SETTING THE BUTTON BACK IN PLACE AND RESTORING THE TENSION, THE FRAME WAS FOUND TO BE FULLY FUNCTIONAL. WITH MARKERS ATTACHED AND FULLY SEATED, THE FRAME ALSO RETURNED GOOD GEOMETRY AND DIVOT ERROR READINGS. NO PROBLEM WAS FOUND. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED THAT THE PERC REFERENCE FRAME WAS DAMAGED AND WOULD "PIVOT" WHEN LOCKED ONTO THE PERC PIN. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337768 PERCUTANEOUS REFERENCE CROSS PIN FRAME INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX MEDTRONIC NAVIGATION, INC 9732353 180118

    Patients

    Seq Age Sex Outcome Treatment
    1