BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINEMASK (TM) TRACKER

    MDR report key: 4599281 · Received March 13, 2015

    Report

    Report Number
    0001811755-2015-00920
    Event Type
    Malfunction
    Date Received
    March 13, 2015
    Date of Event
    February 24, 2015
    Report Date
    February 24, 2015
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    OLO
    PMA / PMN Number
    D228405
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT AVAILABLE FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    DURING THE EVALUATION PROCESS, SPINEMAP® 3D 3.0 - SOFTWARE 6002-670-000 WAS IDENTIFIED AS THE DEVICE ASSOCIATED WITH THE REPORTED EVENT. THE REPORTED EVENT OF INACCURATE NAVIGATION CAN BE CONFIRMED AS A STRYKER EMPLOYEE WAS PRESENT DURING CASE.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A PERCUTANEOUS SPINAL FUSION, THE NAVIGATION ACCURACY WAS OFF APPROXIMATELY 4MM IN THE RIGHT DIRECTION, WHEN LOOKING DOWN ON THE PATIENT IN THE AP VIEW, AND THAT THE INACCURACY WAS NOTICED WHEN CHECKED WITH FLUOROSCOPY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A PERCUTANEOUS SPINAL FUSION, THE NAVIGATION ACCURACY WAS OFF APPROXIMATELY 4MM IN THE RIGHT DIRECTION, WHEN LOOKING DOWN ON THE PATIENT IN THE AP VIEW, AND THAT THE INACCURACY WAS NOTICED WHEN CHECKED WITH FLUOROSCOPY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A PERCUTANEOUS SPINAL FUSION, THE NAVIGATION ACCURACY WAS OFF APPROXIMATELY 4MM IN THE RIGHT DIRECTION, WHEN LOOKING DOWN ON THE PATIENT IN THE AP VIEW, AND THAT THE INACCURACY WAS NOTICED WHEN CHECKED WITH FLUOROSCOPY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175184 SPINEMASK (TM) TRACKER ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO STRYKER INSTRUMENTS-KALAMAZOO 6002-670-000 VERSION 3.0-12

    Patients

    Seq Age Sex Outcome Treatment
    1 (B)(4) SPINEMAP 3D 3.0 SOFTARE VERS 3.0-12