{ "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": "3005075696-2024-00160", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "N", "date_received": "20241121", "manufacturer_address_2": "", "pma_pmn_number": "K203005", "date_of_event": "20230101", "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": "20241121", "manufacturer_contact_f_name": "JUSTIN", "device_date_of_manufacturer": "20190501", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1970691", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20241121", "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": "No", "device_report_product_code": "OLO", "device_age_text": "DA", "device_evaluated_by_manufacturer": "N", "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": [ "Adverse Event Without Identified Device or Use Problem", "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "MO", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "01/01/2023;06/06/2025", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20250828", "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": "20241121", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "NA", "patient_sex": "Unknown", "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": "20250625", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "IS", "manufacturer_contact_city": "MOUNDS VIEW", "mdr_report_key": "20748350", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20241024", "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": "357267373", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "A1-A4: PATIENT INFORMATION IS NOT AVAILABLE. H6: NO PARTS WERE RETURNED FOR PRODUCT 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. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN." }, { "mdr_text_key": "357267374", "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 TOWARD THE END OF LAST CALENDAR YEAR THERE WERE SOME PATIENT DOCUMENTED WITH POST-OPERATIVE NEUROLOGICAL DEFICITS. ONE OF THE PATIENTS HAD THE DEFICIT REPORTED BY NEUROMONITORING. THE DEFICIT WAS NOTED BY NEUROMONITORING AFTER THE SURGEON HAD EXPANDED THE CAGE AND DETACHED IT FROM THE INSERTER AND WAS BACKFILLING THE CAGE USING THE FUNNEL AND TAP THAT ATTACH TO THE INSERTER. THE SURGEON SLAMMED THE FUNNEL DOWN FAIRLY FORCEFULLY RIGHT BEFORE THE NEUROMONITORING REPRESENTATIVE SPOKE UP REGARDING A DEFICIT. IT WAS BELIEVED THAT THIS OCCURRED TO THREE PATIENTS. THE SYSTEM WAS FUNCTIONING AS INTENDED, AND CAUSE ANY INJURY OR DELAY DURING THE SURGERIES. THE SURGEON BELIEVES THAT THE CAGE POSSIBLY DISTRACTED THE DISC SPACE TOO MUCH AND SOMEHOW PUT STRAIN ON THE SPINAL CORD OR NERVE ROOTS. THE MANUFACTURER REPRESENTATIVE SUSPECTED THAT THE DEFICITS WERE CAUSED BY THE CAGES BEING POSTERIOR AND WHEN DETACHING THE CAGE TO POST-PACK IT WITH THE BONE GRAFT, THE CONNECTION OF THE CAGE MAY HAVE BEEN IN A DANGEROUS POSITION IF IT WAS NOT AS ANTERIOR AS IT APPEARED ON NAVIGATION. THE REPRESENTATIVE SUGGESTED USING INTRAOPERATIVE C-ARM DURING EXPANSION AND POST-PACKING OF THE CAGE, BUT THE SURGEON CHOSE TO JUST USE THE NAVIGATION GUIDANCE FOR PLACEMENT AND DID NOT PERFORM ANY INTRAOPERATIVE X-RAYS WHEN PLACING CAGE." }, { "mdr_text_key": "376218007", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE REPORTED THAT THERE WERE NO IN-CASE INCIDENTS ALLEGED OR OBSERVED WITH INSTRUMENTS DURING THE PROCEDURE REGARDING THE SYSTEM. THE ADVERSE EVENT WAS OBSERVED A FEW MONTHS LATER RELATED TO THE CAGE AND HOW IT EXPANDED, NOT THE GUIDANCE SYSTEM." }, { "mdr_text_key": "376218008", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "B5: ADDITIONAL INFORMATION RECEIVED SHOWS THAT THERE IS NO INFORMATION TO REASONABLY SUGGEST THAT THE DEVICE IN THIS REPORT MAY HAVE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY OR THAT THE DEVICE IN THIS REPORT HAS MALFUNCTIONED. THEREFORE, THIS EVENT DOES NOT MEET THE REPORTING REQUIREMENTS IN 21 CFR 803. H6: PATIENT CODE UPDATED TO REFLECT THAT THERE WAS NO INCIDENTS DURING THE CASE. 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": "362341183", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE REPORTED THAT THE SURGEON SUSPECTED THAT THE CAGE WAS CAUSING TOO MUCH EXPANSION/DISTRACTION LEADING TO THE NEURO DEFICIT. THE PATIENT ALL HAD DEGENERATIVE DISC DISEASE. THERE WAS NO SURGICAL INTERVENTION TO TRY TO COUNTERACT THE NEUROLOGICAL DEFICITS ON ANY OF THE CASES." }, { "mdr_text_key": "362341184", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "B3: YEAR IS ONLY VALID. MONTH AND DAY OF EVENT IS UNKNOWN. G3: THE NOTIFIED DATE HAS BEEN UPDATED. 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": "01/09/2025;06/25/2025" } ] }