{ "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": "+1(763)5", "event_type": "Injury", "report_number": "3005075696-2026-00125", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20260808", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20260514", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "55112", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "+1(763)526-5677", "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": "", "date_added": "20260808", "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": "498003", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20260808", "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": "", "device_evaluated_by_manufacturer": "N", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "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" ], "reporter_state_code": "MI", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "08/18/2026", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20260826", "health_professional": "N", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "30", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20260808", "sequence_number_treatment": [ "\"See H11....\"" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "61 YR", "patient_sex": "Male", "patient_weight": "220 LB", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Insufficient Information" ] } ], "distributor_city": "", "date_report": "20260826", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "IS", "manufacturer_contact_city": "Mounds View", "mdr_report_key": "50187245", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20260806", "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": "15448200604", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "Medtronic received information regarding a guidance system used during a sacroiliac and thoracolumbar procedure. It was reported that there was a deviated screw. The implants from the SI fusion appeared to be out of place. It was noted that the patient was affected The patient went in for a follow up when this was noticed. There was no reported delay to the procedure." }, { "mdr_text_key": "15948200605", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "D10: Section D information references the main component of the system. Other relevant device(s) are: Product Id: KIT0001742, Software Version #: 5.2 F12: Patient was affected F15: Deviated screw H3, H6: No products were returned to Medtronic for analysis. Codes B20, C20, 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. 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