{ "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. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-08", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "3005075696-2020-00108", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20200904", "manufacturer_address_2": "", "pma_pmn_number": "K182077", "date_of_event": "20200810", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "COMPANY REPRESENTATIVE", "HEALTH" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20200904", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "957238", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20200904", "brand_name": "MAZOR X STEALTH EDITION", "generic_name": "ORTHOPEDIC STEREOTAXIC INSTRUMENT", "manufacturer_d_name": "MAZOR ROBOTICS LTD", "manufacturer_d_address_1": "5 SHACHAM STREET", "manufacturer_d_address_2": "P.O. BOX 3104", "manufacturer_d_city": "CAESAREA HEFA,IL", "manufacturer_d_state": "", "manufacturer_d_zip_code": "30795", "manufacturer_d_zip_code_ext": "67", "manufacturer_d_country": "", "manufacturer_d_postal_code": "3079567", "device_operator": "HEALTH PROFESSIONAL", "model_number": "TPL0059", "catalog_number": "TPL0059", "lot_number": "", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20200812", "device_report_product_code": "OLO", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "07290109183213", "udi_public": "07290109183213", "openfda": { "device_name": "Orthopedic Stereotaxic Instrument", "medical_specialty_description": "Neurology", "regulation_number": "882.4560", "device_class": "2" } } ], "product_problems": [ "Use of Device Problem", "Insufficient Device Problem Information", "Use of Device Problem", "Insufficient Device Problem Information" ], "reporter_state_code": "MI", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "10/18/2020", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250801", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200904", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Known Impact Or Consequence To Patient", "No Known Impact Or Consequence To Patient" ] } ], "distributor_city": "", "date_report": "20201028", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10494274", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200810", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "320315609", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE REPORTED THAT L5 WAS ACTUALLY S1 AND THE L4 AND S1 SCREWS HAD EQUAL SHIFTS OFF THE CENTER OF THE PEDICLE." }, { "mdr_text_key": "320315610", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "ANALYSIS OF SOFTWARE EXPORTS WAS COMPLETED. CLINICAL EXPORT DATA FILE WAS THOROUGHLY INSPECTED. THE LOG TEXT FILE IS A CHRONOLOGICAL DOCUMENTATION OF THE SOFTWARE DURING OPERATION, INCLUDING TRAJECTORIES SENT BY THE SYSTEM, STAR MARKER (SM) RECOGNITION ACCURACY, ETC. THE LOG FILE WAS EXAMINED RELATIVE TO ALL SPECIFIED INTRAOPERATIVE ACTIONS IN ORDER TO INVESTIGATE AND UNDERSTAND PROCEDURE FLOW. ANALYSIS REVIEWED THE PLANNING OF THE EXECUTED TRAJECTORIES. NO MAJOR ISSUES WERE FOUND. THE PLATFORM USED FOR THIS CASE WAS A SCHANZ SCREW. FROM THE 3D SCAN IT SEEMS THAT THE SCREW WAS INSERTED DEEP ENOUGH IN THE PSIS. NO OTHER ISSUES WERE FOUND WITH THE PLATFORM FIXATION. IT CAN BE SEEN FROM THE PRE-OPERATIVE PLAN THAT THERE ARE NO L5 SCREWS PLANNED. AFTER VALIDATING WITH THE REPRESENTATIVE, IT WAS CONFIRMED THAT THE L5 SCREW REPORT WAS RELATED TO THE S1 LEFT SCREW: \"¿ THE L4 AND L5 (S1) SCREWS HAD EQUAL SHIFTS OFF THE CENTER OF THE PEDICLE¿\". FROM THE PROVIDED POST-OP IMAGE, IT SEEMS THAT A SHIFT OCCURRED AFTER THE S<(>&<)>P REGISTRATION, CREATING A MEDIAL DEVIATION ON THE LEFT SIDE AND A LATERAL DEVIATION ON THE RIGHT SIDE OF L4. THE S1 IMAGE PROVIDED WAS NOT ENTIRELY CONCLUSIVE SINCE THE FULL PROJECTION OF THE SCREW COULDN'T BE SEEN IN THE IMAGE. IN ADDITION, IT WAS MENTIONED IN THE REPORT THAT THE BOTH L3 SCREWS WERE ACCURATE. AFTER REVIEWING ALL AVAILABLE INFORMATION, ANALYSIS CONCLUDED THAT THE MOST PROBABLE CAUSE FOR THE REPORTED DEVIATIONS WAS A PATIENT SHIFT THAT OCCURRED AFTER TAKING THE O-ARM SCAN AND REGISTERING. 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": "205712896", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ANALYSIS RESULTS OF SOFTWARE EXPORTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE. A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE GUIDANCE SYSTEM. TESTING REVEALED THAT THE SYSTEM PASSED AN ADVANCED ACCURACY TEST. THE SYSTEM THEN PASSED THE SYSTEM CHECKOUT AND WAS FOUND TO BE FULLY FUNCTIONAL. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED." }, { "mdr_text_key": "205712897", "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 TO TREAT DEGENERATIVE DISCS WITH FIXATION USING SCREWS AND RODS. IT WAS REPORTED THAT BOTH L3 SCREWS WERE ACCURATELY PLACED BY THE SURGEON, BUT THE L4 SCREWS WERE OFF TRAJECTORY. THE RIGHT SCREW WAS LOW AND LATERAL AND THE LEFT SCREW WAS MEDIAL. THE L5 SCREW WAS ALSO MEDIAL. THE L4 AND L5 SCREWS HAD EQUAL SHIFTS OFF THE CENTER OF THE PEDICLE. THE AMOUNT OF DEVIATION AND CAUSE OF THE DEVIATIONS WERE UNKNOWN. THE DEVIATIONS WERE FOUND AFTER A POST-OP CT SCAN WAS COMPLETED. A REVISION PROCEDURE TO REPOSITION THE SCREWS WAS DONE. 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": "10/28/2020" } ] }