{ "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": "3005075696-2024-00128", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20240920", "manufacturer_address_2": "", "pma_pmn_number": "K230064", "date_of_event": "20240826", "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": "20240920", "manufacturer_contact_f_name": "JUSTIN", "device_date_of_manufacturer": "20230514", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1668150", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20240920", "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": "20240826", "device_report_product_code": "OLO", "device_age_text": "DA", "device_evaluated_by_manufacturer": "Y", "combination_product_flag": "N", "udi_di": "07290115751376", "udi_public": "07290115751376", "openfda": { "device_name": "Orthopedic Stereotaxic Instrument", "medical_specialty_description": "Neurology", "regulation_number": "882.4560", "device_class": "2" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem", "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "LA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "09/05/2024", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20250810", "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": "20240920", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Life Threatening", " R" ], "patient_age": "65 YR", "patient_sex": "Female", "patient_weight": "51 KG", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Cardiac Arrest", "Hemorrhage/Blood Loss/Bleeding", "Cardiac Arrest", "Hemorrhage/Blood Loss/Bleeding" ] } ], "distributor_city": "", "date_report": "20241001", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "IS", "manufacturer_contact_city": "MOUNDS VIEW", "mdr_report_key": "20267550", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20240826", "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": "352265765", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "H3, H6: THE EXPORTS/LOGS HAVE BEEN RETURNED FOR CLINICAL ANALYSIS. THE ANALYSIS IS STILL IN PROGRESS. MULTIPLE PATIENT CODES HAVE BEEN PROVIDED. BELOW CLARIFIES WHAT EACH REPRESENTS. E0602 - THE PATIENT CODED DURING THE PROCEDURE. E0506 - PHYSICIAN NOTICED AN INCREASE IN BLEEDING. 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." }, { "mdr_text_key": "352265766", "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 THE PATIENT CODED DURING THE PROCEDURE. A TEN POINT ACCURACY CHECK WAS PERFORMED WITH NO ISSUE DETECTED. A THREE POINT ACCURACY CHECK/BIST TEST WAS PERFORMED WITH NO ISSUES DETECTED. THE SYSTEM WAS THEN BROUGHT INTO THE OPERATING ROOM(OR) FOR THE PROCEDURE.  THE SCREWS WERE SET VIA K-WIRE. THE PROCEDURE WAS PERFORMED IN TWO SEGMENTS, T9-L1 AND L2 - S1. THE SURGEON EXPOSED THE TOP HALF FIRST, AND DROPPED SCREWS BILATERALLY VIA NAVIGATION. THE SCREW PLACEMENT WAS CONFIRMED VIA FLUOROSCOPY, AND THE SURGEON WAS HAPPY WITH THE SCREW PLACEMENT. THE SYSTEM WAS REMOVED FROM THE PATIENT, TO START THE SECOND SEGMENT, L2-S1. THE PATIENT HAD PREVIOUSLY INSTALLED HARDWARE IN L2-S1, SO THE SURGEON EXPOSED THE BOTTOM HALF OF THE CONSTRUCT, AND REMOVED THE OLD RODS AND SCREWS. THE SYSTEM WAS THEN RECONNECTED TO THE PATIENT, AND S2 REGISTERED WITHOUT ISSUE. K-WIRES WERE INSERTED FOR THE S2 SCREWS, AND THE SCREW WERE PLACED BILATERALLY. ALL NEW SCREWS WERE STIMULATED VIA NEUROMODULATION GREATER THAN 20. BEGINNING L2 AND MOVING TO S1, THE OLD SCREWS WERE REMOVED AND REPLACED FREEHAND. WHEN REMOVING AND REPLACING THE SCREW SET INTO LEFT S1, THE PHYSICIAN NOTICED AN INCREASE IN BLEEDING. THE ANESTHESIOLOGIST THEN NOTED THAT THERE WAS NO PRESSURE ON THE ARTERIAL LINE AND NO WAVEFORM ON THE PULSE OXIMETER. CPR WAS INITIATED AND A STRETCHER WAS BROUGHT IN ON THE OPPOSITE SIDE OF THE BED AS THE SYSTEM, WHILE THE SYSTEM WAS BEING REMOVED. THE PATIENT WAS ALIVE WHEN EXITING THE OPERATING ROOM. THERE WAS NO DELAY TO THE PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT NOTHING IN THE CASE WAS NAVIGATED. THE SET SCREWS AND RODS WERE REMOVED PRIOR TO THE SECOND REGISTRATION. AFTER REGISTRATION, THE S2 SCREWS WERE PLACED PRIOR TO ANYTHING BEING REMOVED. CT-FLUORO WAS USED. IT WAS NOTED THE SURGEON DID NOT WANT THE ROBOT MOUNTED WHILE THEY EXPOSED THE LOWER HALF OF THE CONSTRUCT. THE SEGMENT OF THE CONSTRUCT THAT WAS DONE FREEHAND WAS THE REMOVAL AND REPLACING OF HARDWARE IN THE SAME VOID. IT WAS NOTED THE S2 SCREWS WERE NEW." }, { "mdr_text_key": "353245394", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "SEE B5. H3, H6: THE EXPORTS/LOGS WERE RETURNED FOR CLINICAL ANALYSIS. THE ANALYSIS DETERMINED NO FAILURES WERE FOUND. THE PATIENT'S CARDIAC EVENT (CODE) WAS UNRELATED TO THE PROCEDURE. IT WAS RELATED TO THEIR PRE-EXISTING CARDIAC MEDICAL CONDITIONS AND ANESTHESIA. 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": "353245395", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE REPORTED THE PATIENT WAS FOUND TO HAVE AN UNDERLYING CARDIAC ISSUE. THE ADVERSE OUTCOME WAS UNRELATED TO THE PROCEDURE. THE PATIENT HAD A CARDIAC CONDITION THAT MADE THEM UNFIT FOR SURGERY." } ], "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": "10/01/2024" } ] }