{ "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": "3005075696-2025-00297", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20250630", "manufacturer_address_2": "", "pma_pmn_number": "K182077", "date_of_event": "20250612", "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": [ "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": "20250630", "manufacturer_contact_f_name": "JUSTIN", "device_date_of_manufacturer": "20221129", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2258282", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20250630", "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": "20250616", "device_report_product_code": "OLO", "device_age_text": "DA", "device_evaluated_by_manufacturer": "Y", "combination_product_flag": "N", "udi_di": "07290115751376", "udi_public": "(01)07290115751376(11)221129", "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": "FL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/21/2025", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20250904", "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": "20250630", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "62 YR", "patient_sex": "Female", "patient_weight": "73 KG", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding", "Hemorrhage/Blood Loss/Bleeding" ] } ], "distributor_city": "", "date_report": "20250724", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "IS", "manufacturer_contact_city": "MOUNDS VIEW", "mdr_report_key": "22359127", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20250612", "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": "373899272", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text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}, { "mdr_text_key": "373899273", "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": "379234953", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "H3, H6) CLINICAL ANALYSIS WAS PERFORMED. IN SUMMARY, THE PROBABLE CAUSE OF THE REPORTED DEVIATION WAS A DISCREPANCY BETWEEN THE ACTUAL AND REGISTERED ANATOMY, LIKELY RESULTING FROM BONY WORK AFTER REGISTRATION BEFORE SCREW PLACEMENT SPECIFICALLY, THE REMOVAL OR PARTIAL REMOVAL OF THE FACET JOINTS ON THE RIGHT SIDE WHICH MAY HAVE CAUSED A LATERAL-INFERIOR SHIFT. IT WAS ALSO POSSIBLE THAT THE RIGHT-SIDE FACETECTOMY, ALONG WITH POTENTIAL PATIENT MOVEMENT AFTER THE SECOND REGISTRATION, CONTRIBUTED TO THE INFERIOR SHIFT DETECTED IN THE OPERATING ROOM FOR L2 RIGHT. HOWEVER, THIS COULD NOT BE CONFIRMED, AS ONLY THE L2 RIGHT SCREW WAS EXECUTED AFTER THE SECOND REGISTRATION, AND NO POST-OPERATIVE IMAGING WAS PROVIDED. WHILE THIS CLAIM COULD NOT BE VERIFIED WITH ABSOLUTE CERTAINTY, IT ALSO COULD NOT BE RULED OUT AS A CONTRIBUTING FACTOR TO THE REPORTED INACCURACY. LASTLY, MULTIPLE PROCEDURES HAVE BEEN PERFORMED SINCE, AND NO ISSUES WITH INACCURACY HAVE BEEN REPORTED. ALL PLANNED TRAJECTORIES WERE PLANNED WITH NO OBSERVABLE ISSUES AND THERE WERE NO SKIVING POTENTIALS DETECTED FROM THE PLAN. NO SOFTWARE ANOMALIES WERE DETECTED, ERRORS, OR SIGNS OF EXCESSIVE FORCE TO THE SURGICAL ARM WERE FOUND IN THE LOGS. THE MATCHING ACCURACY OF THE SYSTEM WAS ALSO REVIEWED WITH NO OBSERVABLE ISSUES. CODES B01, C19, AND D15 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": "07/24/2025" } ] }