{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. 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CLINICAL EXPORT DATA FILE WAS THOROUGHLY INSPECTED. THE LOG FILE WAS EXAMINED WITH RESPECT TO ALL INTRAOPERATIVE FLUORO IMAGES IN ORDER TO INSPECT AND UNDERSTAND PROCEDURE WORKFLOW. FLUORO IMAGES WERE CHECKED AND 3D REGISTRATION WAS ATTEMPTED WITH THE REGISTRATION 3D MARKER IMAGES UTILIZED DURING THE OPERATION ON A MAZOR X R & D WORKSTATION. ANALYSIS REVIEWED THE PLANNING MADE FOR THE CASE. NO ISSUES WERE FOUND WITH THE PLANNED TRAJECTORIES. ANALYSIS REVIEWED THE MATCHING ACCURACY OF THE SYSTEM. THE CT-FLUORO MATCHING OF THE VERTEBRAE WERE DETERMINED ACCEPTABLE. ANALYSIS PERFORMED REGISTRATION AND REPRODUCED IT IN ORDER TO FIND ANY SHIFTS BETWEEN THE FLUORO IMAGES AND THE CT SCAN. NO SHIFTS WERE NOTICED, AND THE REGISTRATION DETERMINED TO BE ACCEPTABLE. REPORTED LATERAL DEVIATION OF 1 SCREW (T8 LEFT), IT WAS NOTICED THAT THERE WAS LATERAL DEVIATION AT T9 LEFT AS WELL. BY EXAMINING THE PLANNING MADE, IT WAS NOTICED THAT THE TOP TRAJECTORIES (T8, T9) HAVE DEVIATED LATERALLY COMPARED TO THE PLAN, WHILE THE LOWER TRAJECTORIES (T11, T12) HAVEN¿T DEVIATED. THE FIXATION PLATFORM USED WAS A HEAD PINS IN SPINOUS PROCESS (SP) OF T8 AND T12. AFTER INVESTIGATING THE FLUOROSCOPY SCANS PROVIDED, IT SEEMS THAT THE TOP PIN (T8) WAS NOT DRILLED INTO THE SP AND NOT FIXATED TO A BONY TISSUE WHILE THE BOTTOM PIN (T12) IS PARTIALLY DRILLED INTO THE SP. ANALYSIS REVIEWED ALL AVAILABLE INFORMATION AND CONCLUDED THE ROOT CAUSE OF THE DEVIATIONS TO BE INADEQUATE PLATFORM FIXATION, MOST PROBABLY LEADING TO A PLATFORM SHIFT OF THE TOP TRAJECTORIES CONSIDERING THAT THE EXECUTION STARTED FROM T8 LEFT WHILE THE HEAD PIN WAS NOT ATTACHED WELL TO THE ANATOMY. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED." }, { "mdr_text_key": "219130847", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED." }, { "mdr_text_key": "219130848", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT DURING A T8-T12 TRAUMA BURST FRACTURE, THE LEFT T8 SCREW WAS DEVIATED LATERAL BY ABOUT 5 MM. THE LEFT T8 SCREW WAS PLACED FIRST AND FOUND TO BE DEVIATED ON A POST-OP CT. THE REST OF THE SCREWS WERE PLACED ACCURATELY. THE CAUSE OF THE DEVIATION WAS UNKNOWN. A REVISION WAS SCHEDULED, BUT THE MANUFACTURER REPRESENTATIVE NOTED THAT IT MAY BE CANCELLED DUE TO UNRELATED COMPLICATIONS. THE PROCEDURE WAS DELAYED LESS THAN AN HOUR." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "02/03/2021" } ] }