{ "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": "CAESAREA BUSINESS PARK", "event_location": "", "report_to_fda": "", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "MN", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "8200 CORAL SEA STREET NE MVS21", "manufacturer_g1_city": "CAESAREA HEFA,IL", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "76352656", "event_type": "Injury", "report_number": "3005075696-2025-00263", "type_of_report": [ "Initial submission", "Followup", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20250505", "manufacturer_address_2": "", "pma_pmn_number": "K230064", "date_of_event": "20250421", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "55112", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "7635265677", "noe_summarized": "1", "manufacturer_contact_l_name": "ELLIS", "source_type": [ "Health Professional", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "3079830", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "763", "date_added": "20250505", "manufacturer_contact_f_name": "JUSTIN", "device_date_of_manufacturer": "20200716", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "287572", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20250505", "brand_name": "MAZOR X SYSTEM", "generic_name": "ORTHOPEDIC STEREOTAXIC INSTRUMENT", "manufacturer_d_name": "MAZOR ROBOTICS LTD", "manufacturer_d_address_1": "1 HAESHEL STREET. (BUILDING C)", "manufacturer_d_address_2": "CAESAREA BUSINESS PARK", "manufacturer_d_city": "CAESAREA HEFA,IL", "manufacturer_d_state": "", "manufacturer_d_zip_code": "30798", "manufacturer_d_zip_code_ext": "30", "manufacturer_d_country": "IS", "manufacturer_d_postal_code": "3079830", "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": "20250422", "device_report_product_code": "OLO", "device_age_text": "DA", "device_evaluated_by_manufacturer": "Y", "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": [ "Incorrect, Inadequate or Imprecise Result or Readings", "Incorrect, Inadequate or Imprecise Result or Readings" ], "reporter_state_code": "FL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "05/01/2025;05/07/2025;06/05/2025", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20250826", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "30", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "7635", "patient": [ { "patient_sequence_number": "1", "date_received": "20250505", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "NA", "patient_sex": "Male", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Unspecified Nervous System Problem", "No Clinical Signs, Symptoms or Conditions", "Unspecified Nervous System Problem", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20250606", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "IS", "manufacturer_contact_city": "MOUNDS VIEW", "mdr_report_key": "21960601", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20250421", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "30798", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "MAZOR ROBOTICS LTD", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "N", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "369544833", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT DURING A COMPUTED TOMOGRAPHY TO FLUORO CASE FOR AN L2¿S2 OPEN PROCEDURE, ALL SCREWS DEVIATED FROM THEIR PLANNED TRAJECTORIES. THE PROCEDURE INCLUDED TITANIUM INTERBODIES PLACED FROM L2¿S1 (LATERAL CAGES) AND AN ALIF AT L5¿S1 WITH PLATES, SCREWS, AND INTERBODIES. CORTICAL TRAJECTORIES WERE USED, AND NO SKIN PRESSURE WAS NOTED. COMPUTED TOMOGRAPHY TO FLUORO REGISTRATION WAS PERFORMED USING L4 AS THE REGISTRATION LEVEL, ACHIEVING GREEN VALUES FROM L2¿S1. HOWEVER, NOTICEABLE SHIFTS WERE OBSERVED AT L2, L3, AND L4 DURING SCREW PLACEMENT. NAVIGATION ALIGNMENT WAS INCONSISTENT ACROSS ALL LEVELS, WITH THE SYSTEM SHOWING THE DRILL AS EITHER SUPERIOR OR INFERIOR, REQUIRING OCCASIONAL MANUAL ADJUSTMENT OF THE ARM GUIDE. THE SCREWDRIVER AND DRIVER EXHIBITED SIMILAR INCONSISTENCIES, WHILE THE TAP CONSISTENTLY ALIGNED WELL WITH NAVIGATION. A FINAL SNAPSHOT CONFIRMED THAT ALL SCREWS DEVIATED FROM THEIR PLANNED PATHS, APPEARING RANDOM. DUE TO ANTERIOR BREACHES, THE SURGEON REMOVED BILATERAL SCREWS AT L3 AND THE LEFT SCREW AT L5, AND SKIPPED SCREW PLACEMENT AT S2. ALL S CREWS PLACED WERE MORE PROW THAN PLANNED, WITH GENERALLY SHALLOW DEPTHS EXCEPT AT L3, WHERE THE SCREW SKIVED ANTERIORLY. BOTH SCREWS AT S1 DEVIATED INFERIORLY BY MORE THAN 4 MILLIMETERS IN THE SAGITTAL PLANE. THE SURGEON COMPLETED THE CASE TO THE BEST OF THEIR ABI LITY BUT WAS UNABLE TO FOLLOW THE ORIGINAL PLAN DUE TO THESE DEVIATIONS. THE PROCEDURE WAS DELAYED AN HOUR OR LONGER. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE SHIFTS WERE PRESENT DURING VERIFICATION BETWEEN THE CT AND X-RAY. AT EACH TRAJECTORY, THE NAVIGATION WAS POSITIONED EITHER MEDIAL OR LATERAL IN THE AXIAL / SAGITTAL AXIS WITH THE SHORT DRILL. THE SHORT CORTICAL TAP HAD NO VARIANCE AND THE CORTICAL SCREWDRIVER WAS MANUALLY RE-POSITIONED BY GENTLY PRESSING UP AGAINST AND/OR AWAY (DEPENDENT ON LEVEL) ON TO THE ARM GUIDE TO \"LINE UP\" WITH NAVIGATION. A DIVOT CHECK WAS PERFORMED AT THE VERY FIRST TRAJECTORY. THE ACCURACY CHECK SHOWED PERFECT ALIGNMENT IN THE DIVOT. IN ADDITION, THE DRILL WAS REVERIFIED AND THE PASSIVE PLANAR PROBE WAS PLACED ON THE SPINOUS PROCESS WHICH ALL SHOWED NAVIGATION WAS CORRECT. IT WAS CONFIRMED WITH 2D X-RAY IMAGES THAT SCREW DEVIATIONS WERE OFF. IN ADDITION, THE SURGEON NOTICED THAT THE SCREWS WERE SIGNIFICANTLY \"MORE\" PROUD THAN WHAT WAS DEPICTED ON THE PLAN. NOTHING WAS UNIFORM REGARDING SCREW PLACEMENT WITH THE ROBOT. WHAT WAS STRANGE, ACCORDING TO THE MANUFACTURER REPRESENTATIVE, WAS THAT THE DEPTH DIFFERENCES WERE SHALLOW TO THE PLAN (ABOUT 5 THREAD PITCHES ABOVE PLANNED LOCATION ON BONE) AND THE LACK OF PATTERN WITH THE DEVIATIONS. NOTHING EXTERNALLY OCCURRED ENVIRONMENTALLY IN THE OPERATING ROOM (OR) THAT WOULD HAVE CAUSED A SHIFT TO THE MANUFACTURER REPRESENTATIVE'S KNOWLEDGE. POST-CASE, THE MANUFACTURER REPRESENTATIVE WAS ABLE TO REVIEW THE CASE AND THERE THEY WERE WAS ABLE TO CORRECT A FEW LEVELS OF ¿SHIFT¿ WITH MANUAL ADJUSTMENT OF THE SEGMENTATION LINES. THE PATIENT EXPERIENCED FOOT DROP. THE DEVIATION WAS BETWEEN 3.5 TO 10 MM." }, { "mdr_text_key": "369544834", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO PERFORM A SYSTEM CHECK OUT AND THEY FOUND THE SYSTEM FUNCTIONED AS INTENDED. B01, C19, D14 IS APPLICABLE TO THE SYSTEM CHECKOUT. THE EXPORTS/LOGS WERE RETURNED FOR CLINICAL ANALYSIS. THE ANALYSIS IS STILL IN PROGRESS. B21, C21, D16 ARE APPLICABLE TO THE CLINICAL ANALYSIS. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN." }, { "mdr_text_key": "369637116", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "H6: PATIENT CODE <(>&<)> F CODE CORRECTED TO CAPTURE THE FOOT DROP MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN." }, { "mdr_text_key": "371568767", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN." }, { "mdr_text_key": "371568768", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE CASE WAS STAGED CASE AND ALL THE INTERBODIES WERE IN THE CT." }, { "mdr_text_key": "372239240", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "H3, H6: THE EXPORTS/LOGS WERE RETURNED FOR CLINICAL ANALYSIS. THE ANALYSIS DETERMINED THAT THE PROBABLE CAUSES OF THE REPORTED DEVIATIONS INCLUDE FALSE-POSITIVE REGISTRATION AND INADEQUATE PLATFORM FIXATION. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "1 HAESHEL STREET. (BUILDING C)", "distributor_zip_code": "", "manufacturer_contact_postal_code": "55112", "manufacturer_contact_exchange": "763", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "05/06/2025;05/28/2025;06/06/2025" } ] }