{ "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": "3005075696-2025-00365", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20251015", "manufacturer_address_2": "", "pma_pmn_number": "K230064", "date_of_event": "20250716", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "55112", "reporter_occupation_code": "003", "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": "SP", "manufacturer_contact_area_code": "763", "date_added": "20251015", "manufacturer_contact_f_name": "JUSTIN", "device_date_of_manufacturer": "20191204", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "381801", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20251015", "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": "20250929", "device_report_product_code": "OLO", "device_age_text": "DA", "device_evaluated_by_manufacturer": "Y", "combination_product_flag": "N", "udi_di": "07290109183213", "udi_public": "(01)07290109183213(11)191204", "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": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "11/12/2025", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20260211", "health_professional": "", "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": "20251015", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "NA", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Nerve Damage", "Nerve Damage" ] } ], "distributor_city": "", "date_report": "20251202", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "IS", "manufacturer_contact_city": "MOUNDS VIEW", "mdr_report_key": "23281521", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20250716", "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": "392702900", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "H3, H6: A CLINICAL ANALYSIS WAS PERFORMED FOR THIS EVENT. ALL PLANNED TRAJECTORIES WERE PLANNED WITH NO OBSERVABLE ISSUES. TWO SNAPSHOTS AND TWO REGISTRATIONS WERE RECORDED FROM THE LOGS. IN THIS CASE, A DIVOT ACCURACY CHECK WAS NOT PERFORMED, WHICH IS PERFORMED WHEN ACCURACY MAY BE IN QUESTION. NAVIGATIONAL ACCURACY IS NOTED IN THE MANUFACTURER'S MANUAL TO BE PERFORMED FREQUENTLY DURING LIVE NAVIGATION. IT WAS NOTED IT WAS POSSIBLE THAT THERE WAS AN ISSUE WITH THE INTEGRATION BETWEEN THE REFERENCE FRAME, SNAPSHOT, AND NAVIGATION CAMERA. IT WAS REPORTED THAT \"PROBLEMS WERE ENCOUNTERED WHEN TRYING TO FIND THE POSITION OF THE NAVIGATION CAMERA TO SEE THE ROBOTIC REFERENCE FRAME AND THE SNAPSHOT FRAME AT THE SAME TIME, BUT AFTER ACHIEVING, THE NAVIGATION WAS PROPER.\". THE LOG FILES SHOWED NO INDICATION OF EXCESSIVE FORCE APPLIED TO THE SURGICAL ARM OR ANY ABNORMAL BEHAVIOR. FOLLOWING THIS CASE, MULTIPLE CASES WERE PERFORMED USING THIS SYSTEM. CODES B01, C13, AND D11 ARE APPLICABLE. 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": "382436662", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "H3, H6) CLINICAL DATA WAS RECEIVED AND IS PENDING ANALYSIS. CODES B21, C21, AND D16 ARE APPLICABLE. 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": "382436663", "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, VERTEBRAL FUSION, 2 LUMBAR LEVELS. IT WAS REPORTED THAT AFTER FINISHING THE REGISTRATION, THE ARM WAS SENT TO THE PLANNED TRAJECTORIES AND IT WAS NOT ALIGNED WHAT WAS SHOWN IN THE SCREEN IN THE GUIDANCE SYSTEM VERSUS REALITY. THEY REPEATED THE PROCEDURE FROM SNAPSHOT. A NEW SNAPSHOT AND REGISTRATION (AP AND LATERAL) WERE PERFORMED AND THE EQUIPMENT WAS FINE. THEY HAD PROBLEMS FOR THE CAMERA TO MAKE THE SNAPSHOT. THE PATIENT'S NERVE ROOT WAS AFFECTED AND THIS WAS REALIZED AFTER FINISHING THE SURGERY. THE SURGICAL DELAY WAS APPROXIMATELY 1-HOUR. TRAJECTORY WAS MISALIGNED BY GREATER THAN 10 MILLIMETERS (MM). ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE SNAPSHOT ISSUE WAS NOT RELATED TO THE INACCURACY/INJURY EVENT. PROBLEMS WERE ENCOUNTERED WHEN TRYING TO FIND THE POSITION OF THE NAVIGATION CAMERA TO SEE THE ROBOTIC REFERENCE FRAME AND THE SNAPSHOT FRAME AT THE SAME TIME, BUT AFTER ACHIEVING, THE NAVIGATION WAS PROPER." } ], "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": "12/02/2025" } ] }