BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINEMAP® 3D 2.0 SOFTWARE

    MDR report key: 4192687 · Received October 22, 2014

    Report

    Report Number
    0001811755-2014-03714
    Event Type
    Malfunction
    Date Received
    October 22, 2014
    Date of Event
    September 25, 2014
    Report Date
    September 25, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HAW
    PMA / PMN Number
    K012380
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT WAS CONFIRMED DURING THE REVIEW OF LOG FILES AND PATIENT. THE REVIEW INDICATED THAT THE EVENT WAS DUE TO A DIFFERENT SPINE POSITION DURING REGISTRATION AGAINST THE PRE-OPERATIVE SCAN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SPINAL FUSION PROCEDURE OF T12 - L3 USING POINT-TO-POINT REGISTRATION WITH NAVIGATION SYSTEM II, THE SURGEON STATED THAT THE UPPER LEVELS AROUND T11 - L2 WERE INACCURATE FROM A LATERAL PERSPECTIVE. THE REGISTRATION WAS NEVER ACCEPTED AFTER TWO ATTEMPTS AT SURFACE REFINING. AS THE ISSUE WAS NOTICED PRIOR TO INSERTION OF VERTEBRAL SCREWS, NAVIGATION WAS ABORTED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING TRADITIONAL METHODS. NO ADVERSE CONSEQUENCES, NO MEDICAL INTERVENTION, AND NO SURGICAL DELAY WERE REPORTED WITH THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SPINAL FUSION PROCEDURE OF T12 - L3 USING POINT-TO-POINT REGISTRATION WITH NAVIGATION SYSTEM II, THE SURGEON STATED THAT THE UPPER LEVELS AROUND T11 - L2 WERE INACCURATE FROM A LATERAL PERSPECTIVE. THE REGISTRATION WAS NEVER ACCEPTED AFTER TWO ATTEMPTS AT SURFACE REFINING. AS THE ISSUE WAS NOTICED PRIOR TO INSERTION OF VERTEBRAL SCREWS, NAVIGATION WAS ABORTED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING TRADITIONAL METHODS. NO ADVERSE CONSEQUENCES, NO MEDICAL INTERVENTION, AND NO SURGICAL DELAY WERE REPORTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671091 SPINEMAP® 3D 2.0 SOFTWARE NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW STRYKER INSTRUMENTS-KALAMAZOO VERSION 2.0-22

    Patients

    Seq Age Sex Outcome Treatment
    1