{ "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": "3005075696-2024-00140", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20241004", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20240909", "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": "20241004", "manufacturer_contact_f_name": "JUSTIN", "device_date_of_manufacturer": "20230522", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "712377", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20241004", "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", "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": [ "Incorrect, Inadequate or Imprecise Result or Readings", "Incorrect, Inadequate or Imprecise Result or Readings" ], "reporter_state_code": "NC", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "01/27/2025;03/12/2025", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20250821", "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": "20241004", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "65 YR", "patient_sex": "Female", "patient_weight": "52 KG", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Unspecified Nervous System Problem", "Unspecified Nervous System Problem" ] } ], "distributor_city": "", "date_report": "20250313", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "IS", "manufacturer_contact_city": "MOUNDS VIEW", "mdr_report_key": "20370198", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20240909", "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": "366009496", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "H3, H6) CLINICAL DATA WAS RECEIVED FOR ANALYSIS. ALL PLANNED TRAJECTORIES WERE PLANNED WITH NO OBSERVABLE ISSUES. NO INTRA/POST-OPER ATIVE SCANS WERE PROVIDED TO CONFIRM THE REPORTED DEVIATIONS. ACCORDING TO THE 3D RECONSTRUCTION MODEL, THE MIDLINE INCISION WAS FAR FROM THE PLAN OF THE RIGHT TRAJECTORIES' ENTRY POINTS COMPARED TO THE LEFT SIDE. THEREFORE, IT WAS LIKELY THAT RIGHT TRAJECTORIES WERE SUBJECTED TO SOFT-TISSUE PRESSURE ON THE TOOLS WHILE INSTRUMENTING. ADDITIONALLY, A SINGLE CLAMP WAS ATTACHED AT T8, AND THE OPERATED VERTEBRAE WERE T4-T10, WHICH WOULD MAKE OPERATING ON T5 AND T4 OFF-LABEL ACCORDING TO THE SYSTEM'S GUIDANCE PROCEDURES. THE INVESTIGATION TEAM THOROUGHLY EXAMINED THE SYSTEM'S LOG FILES. ACCORDING TO THE LOG FILES, THE ARM REACHED PLANNED DESTINATION SINCE THE DESTINATION AND CURRENT POINTS WERE EQUIVALENT, MEANING THAT THE ARM REACHED THE DESIRED TRAJECTORIES THAT WERE REGISTERED AND THERE WERE NO \"ARM OUT OF TRAJECTORY\" ERRORS RECORDED. ADDITIONALLY, NO EXCESSIVE FORCE APPLIED ON THE ARM WAS OBSERVED OR ANY SOFTWARE ANOMALIES. IN SUMMARY, IT WAS CONCLUDED THAT THE PROBABLE CAUSE OF THE REPORTED INACCURACY WAS SOFT-TISSUE PRESSURE APPLIED ON THE TOOLS WHILE INSTRUMENTING. ADDITIONALLY, OFF-LABEL USAGE OF THE CLAMP WAS OBSERVED AND IT MAY HAVE CONTRIBUTED TO THE DEVIATION. HOWEVER, WITHOUT INTRA/POST-OPERATIVE IMAGES, IT WAS HARD TO CONFIRM. IT WAS NOTED IT WAS HELPFUL TO PERFORM ANATOMY CHECKS THROUGHOUT THE CASE TO ENSURE ACCURACY AND IDENTIFY ANY POTENTIAL SHIFTS IN ANATOMY. PREVIOUSLY REPORTED CODE, B01, IS APPLICABLE AS WELL AS NEWLY REPORTED CODES, C13, AND 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": "353359132", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "H3, H6) THE SYSTEM WAS INSPECTED AND NO FAULTS WERE FOUND. THE UNIT WAS ACCURATE AND A STRESS TEST PASSED ON THE FIRST ATTEMPT AFTER ENTERING IT IN THE ANALYZER. CODES B01, C19, AND D14 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. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN." }, { "mdr_text_key": "353359133", "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, A T10 TO T4 EXTENSION TO A PREVIOUS CONSTRUCT. IT WAS REPORTED THAT THE SURGEON STARTED INSERTING ALL SCREWS ON THE RIGHT SIDE FIRST, STARTING FROM T10 AND GOING DOWN TO T4. WHEN THE SURGEON TAPPED T4, THE NON-MEDTRONIC NEUROMONITORING SYSTEM INDICATED THAT ALL MOTOR FUNCTIONS WERE LOST IN THE PATIENT'S LOWER EXTREMITIES. THE SURGEON USED A BALL-TIP SEALER TO FEEL THAT THERE WAS NO WALL ON THE MEDIAL SIDE OF THE T4 PEDICLE. THEY WERE UNSURE WHY TAPPING WAS INACCURATE BUT SUSPECTED EITHER SKIVING OR PATIENT MOVEMENT. THEY DID NOT OBSERVE ANY SOFT TISSUE PRESSURE ON THE CANNULA NOR DEFLECTION OF THE CANNULA FROM THE GELPEE. THE SURGEON ALSO DID NOT OBSERVE ANY CEREBROSPINAL FLUID (CSF) LEAKAGE. THE SURGEON MOVED THE ROBOT OUT OF THE WAY AND USED FREEHAND NAVIGATION TO INSERT THE SCREW AT T4. THE SURGEON FELT THAT THE T4 SCREW ON THE RIGHT SIDE WAS SCREWED APPROPRIATELY. THE SURGEON THEN ABORTED NAVIGATION ENTIRELY AND PROCEEDED TO COMPLETE THE CASE BY INSERTING THE T10 THROUGH T4 SCREWS ON THE LEFT SIDE BY FREEHAND. THE SURGEON WAS FRUSTRATED BECAUSE OF THE PATIENT HARM, BUT WILL CONTINUE TO USE THE ROBOT FOR FUTURE CASES. THERE WAS NO SUSPICION THAT THE SYSTEM WAS NOT PERFORMING AS INTENDED. THE PATIENT WAS ASSESSED TWO HOURS AFTER THE CASE TO SEE IF THEY HAD MOTOR FUNCTIONS TO THEIR LOWER EXTREMITIES, BUT THE PATIENT WAS STILL SLEEPING DUE TO THE ANESTHESIA. THE PATIENT'S STATE WAS STILL PENDING. THE SURGICAL DELAY WAS ABOUT 30 MINUTES. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT MOTOR FUNCTION WAS RESTORED. THE 2 SCREWS PLACED BY THE GUIDANCE SYSTEM WERE REVISED DUE TO THE MEDIAL DEVIATIONS OF LESS THAN 3.5 MILLIMETERS (MM). THE PATIENT HAD STAYED IN THE HOSPITAL UNTIL REVISION COULD BE COMPLETED." }, { "mdr_text_key": "364650732", "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." } ], "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": "02/21/2025;03/13/2025" } ] }