{ "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": "3005075696-2025-00359", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20251007", "manufacturer_address_2": "", "pma_pmn_number": "K203005", "date_of_event": "20250915", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "55112", "reporter_occupation_code": "OTHER", "manufacturer_contact_plocal": "7635265677", "noe_summarized": "1", "manufacturer_contact_l_name": "ELLIS", "source_type": [ "Foreign", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "3079830", "manufacturer_g1_state": "", "reporter_country_code": "CA", "manufacturer_contact_area_code": "763", "date_added": "20251007", "manufacturer_contact_f_name": "JUSTIN", "device_date_of_manufacturer": "20230519", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "916055", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20251007", "brand_name": "MAZOR X SYSTEM", "generic_name": "ORTHOPEDIC STEREOTAXIC INSTRUMENT", "manufacturer_d_name": "MAZOR ROBOTICS LTD", "manufacturer_d_address_1": "1 HAESHEL STREET. 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IN SUMMARY, THE ANALYSIS CONCLUDED THE COMPLAINT WAS CONFIRMED. ALL PLANNED TRAJECTORIES WERE PLANNED WITH NO OBSERVABLE ISSUES. THE INVESTIGATING TEAM HAS REVIEWED THE MATCHING ACCURACY OF THE SYSTEM. THE CT-FLUORO MATCHING OF THE VERTEBRAE WERE DETERMINED ACCEPTABLE WITH GREEN VALUES AND NO SHIFTS WERE DETECTED BETWEEN THE CT AND FLOURO IMAGES. ACCORDING TO THE LOG FILES, A SNAPSHOT WAS TAKEN TWICE; ONCE AFTER COMPLETING THE 3D SCAN AND ONCE DURING THE OPERATION, AFTER MOVING THE SURGICAL ARM TO L2 RIGHT. THE DISTANCE BETWEEN TIP AND DIVOT WAS OUT OF RANGE, AT > 2MM. THE ADDITIONAL REGISTRATION PERFORMED FIXED THE ISSUE. THEREFORE, PATIENT MOVEMENT WAS FOUND TO BE THE CAUSE. WHEN PERFORMING A PATIENT ACCURACY CHECK, IF THE DISPLAYED IMAGE IS INACCURATE, IT LIKELY INDICATES PATIENT MOTION RELATIVE TO THE ROBOTIC SYSTEM, AND A NEW REGISTRATION IS REQUIRED. PREVIOUSLY REPORTED CODES, B01 AND C19 ARE APPLICABLE, AS WELL AS NEWLY REPORTED CODE, D11. 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": "381887469", "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 AN L2-L3 FUSION PROCEDURE USING COMPUTED TOMOGRAPHY-FLUORO REGISTRATION, NAVIGATION WITH THE GUIDANCE SYSTEM APPEARED TO BE INACCURATE BY 2 MILLIMETERS (MM), DEEP ON THE RIGHT SIDE OF L2 WHEN USING THE DILATOR OR THE PASSIVE PLANAR PROBE. THIS RESULTED IN A NERVE INJURY TO THE PATIENT. ANOTHER SNAPSHOT WAS PERFORMED AS A TROUBLESHOOTING STEP, WHICH DID NOT RESOLVE THE ISSUE. THE SYSTEM WAS THEN RE-REGISTERED, WHICH RESOLVED THE NAVIGATION INACCURACY. SURGICAL DELAY WAS LESS THAN ONE-HOUR. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE PATIENT HAD SOME NUMBNESS/TINGLING. THEY HAD NOT MOBILIZED MUCH AS THEY WERE STILL RECOVERING, SO IT WAS UNKNOWN WHETHER IT WOULD MATERIALIZE TO ANY SORT OF DEFICIT." }, { "mdr_text_key": "381887470", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "H6) THE SYSTEM WAS SERVICED IN THE FIELD. IN SUMMARY, THE SYSTEM PERFORMED AS INTENDED AND PASSED ALL CHECK-OUT TESTING WITHIN S PECIFICATIONS. CODES B01, C19, AND D14 ARE APPLICABLE. H6) CLINICAL DATA WAS RECEIVED AND IS PENDING ANALYSIS. CODES B21, C21, AND D16 ARE APPLICABLE. H6) MULTIPLE ANNEX E CODES WERE APPLIED TO CAPTURE THE PATIENT IMPACT. E013403 CAPTURES THE TINGLING, E0127 CAPTURES THE NUMBNESS, AND E0123 CAPTURES THE NERVE INJURY. A1-5) PATIENT INFORMATION CANNOT BE PROVIDED DUE TO REGIONAL PRIVACY REGULATIONS. 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. 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": "11/25/2025" } ] }