BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINEMASK (TM) TRACKER

    MDR report key: 4654429 · Received April 2, 2015

    Report

    Report Number
    0001811755-2015-01239
    Event Type
    Malfunction
    Date Received
    April 2, 2015
    Date of Event
    March 16, 2015
    Report Date
    March 18, 2015
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    OLO
    PMA / PMN Number
    D228405
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE EVALUATION PROCESS, SPINEMAP® 3D 3.0 - SOFTWARE 6002-670-000 WAS IDENTIFIED TO BE 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 THAT DURING A L5-S1 PERCUTANEOUS SPINE FUSION AT THE HEALTHCARE FACILITY, THE SURGEON DETERMINED WITH TACTILE MEANS THAT NAVIGATION WAS INACCURATE. THE SURGEON CONTINUED TO USE NAVIGATION AND FLUOROSCOPY THROUGHOUT THE PROCEDURE AND REPORTED THAT THE ACCURACY OF THE SYSTEM WOULD CHANGE CONTINUOUSLY FROM BEING ACCURATE TO UP TO 5 MM HIGH AT DIFFERENT POINTS IN THE PROCEDURE. IT WAS REPORTED THAT THERE WAS NO RETRACTION AND THE SURGEON DID NOT EXCESSIVELY LEAN ON THE PATIENT, MOVE THE SKIN OR MANIPULATE THE SOFT TISSUE. RESPIRATION HAD BEEN HALTED FOR MASK CAPTURE AND 3D SPIN. THE CASE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; THE PATIENT WAS NOT AFFECTED AND THERE WERE NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A L5-S1 PERCUTANEOUS SPINE FUSION AT THE HEALTHCARE FACILITY, THE SURGEON DETERMINED WITH TACTILE MEANS THAT NAVIGATION WAS INACCURATE. THE SURGEON CONTINUED TO USE NAVIGATION AND FLUOROSCOPY THROUGHOUT THE PROCEDURE AND REPORTED THAT THE ACCURACY OF THE SYSTEM WOULD CHANGE CONTINUOUSLY FROM BEING ACCURATE TO UP TO 5 MM HIGH AT DIFFERENT POINTS IN THE PROCEDURE. IT WAS REPORTED THAT THERE WAS NO RETRACTION AND THE SURGEON DID NOT EXCESSIVELY LEAN ON THE PATIENT, MOVE THE SKIN OR MANIPULATE THE SOFT TISSUE. RESPIRATION HAD BEEN HALTED FOR MASK CAPTURE AND 3D SPIN. THE CASE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; THE PATIENT WAS NOT AFFECTED AND THERE WERE NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A L5-S1 PERCUTANEOUS SPINE FUSION AT THE HEALTHCARE FACILITY, THE SURGEON DETERMINED WITH TACTILE MEANS THAT NAVIGATION WAS INACCURATE. THE SURGEON CONTINUED TO USE NAVIGATION AND FLUOROSCOPY THROUGHOUT THE PROCEDURE AND REPORTED THAT THE ACCURACY OF THE SYSTEM WOULD CHANGE CONTINUOUSLY FROM BEING ACCURATE TO UP TO 5 MM HIGH AT DIFFERENT POINTS IN THE PROCEDURE. IT WAS REPORTED THAT THERE WAS NO RETRACTION AND THE SURGEON DID NOT EXCESSIVELY LEAN ON THE PATIENT, MOVE THE SKIN OR MANIPULATE THE SOFT TISSUE. RESPIRATION HAD BEEN HALTED FOR MASK CAPTURE AND 3D SPIN. THE CASE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; THE PATIENT WAS NOT AFFECTED AND THERE WERE NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    218025 SPINEMASK (TM) TRACKER ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO STRYKER INSTRUMENTS-KALAMAZOO 6002-670-000 VERSION 3.0

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR (B)(4) SPINEMAP 3D 3.0 SOFTWARE VERS. 3.0