BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    MDR report key: 3211657 · Received July 8, 2013

    Report

    Report Number
    1723170-2013-00500
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    June 11, 2013
    Report Date
    June 11, 2013
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER FIELD NOT SUFFICIENT TO HOLD ENTIRE NUMBER OF ALPHA/NUMERIC DIGITS. AS PROVIDED BY THE SITE, PATIENT IDENTIFIER IS (B)(6). FOLLOW-UP INVESTIGATION BY MEDTRONIC REPRESENTATIVE FINDS THE INACCURACY WAS LESS THAN APPROXIMATELY 10MM. THE SURGEON PERFORMED A BIG DECOMPRESSION THAT DESTABILIZED THE SPINE AND DUE TO HARDER THAN NORMAL BONE, A LARGE AMOUNT OF FORCE WAS APPLIED TO THE SPINE POST DECOMPRESSION; CAUSING THE SPINE AND VERTEBRAL BODIES TO MOVE. THE SYSTEM AND INSTRUMENTS WERE CHECKED-OUT, TESTED, AND FOUND TO BE ACCURATE AND FULLY FUNCTIONAL. NO FURTHER ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE IN A SPINE PROCEDURE, THE SURGEON ALLEGED AN INACCURACY ON THE RIGHT SIDE ONLY. FARTHER AWAY FROM SPINE CLAMP MORE INACCURACY WAS NOTED. LEFT SIDE WAS ACCURATE. A LARGE DECOMPRESSION WAS DONE BEFORE SPIN FROM L2-S1, OPEN SPINE CLAMP WAS PLACED ON L1. IT WAS NOTED THAT THE PATIENT HAD HARDER THAN NORMAL BONE, REQUIRING INCREASED FORCE APPLIED TO THE SPINE. THE SURGEON ADJUSTED FOR THE INACCURACY; C-ARM WAS BROUGHT IN FOR CONFIRMATION. THE PROCEDURE WAS COMPLETED WITHOUT THE USE OF NAVIGATION. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309103 STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. TREON

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR