{ "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": "3005075696-2025-00300", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20250701", "manufacturer_address_2": "", "pma_pmn_number": "K182077", "date_of_event": "20250111", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "55112", "reporter_occupation_code": "OTHER HEALTH CARE PROFESSIONAL", "manufacturer_contact_plocal": "7635265677", "noe_summarized": "1", "manufacturer_contact_l_name": "ELLIS", "source_type": [ "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "3079830", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "763", "date_added": "20250701", "manufacturer_contact_f_name": "JUSTIN", "device_date_of_manufacturer": "20230125", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1143519", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20250701", "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": "07290115751376", "udi_public": "(01)07290115751376(11)230125", "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": "IL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20250807", "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": "20250701", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other", " H" ], "patient_age": "74 YR", "patient_sex": "Male", "patient_weight": "46 KG", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Bacterial Infection", "Pain", "Fungal Infection", "Post Operative Wound Infection", "Bacterial Infection", "Pain", "Fungal Infection", "Post Operative Wound Infection" ] } ], "distributor_city": "", "date_report": "20250701", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "IS", "manufacturer_contact_city": "MOUNDS VIEW", "mdr_report_key": "22373501", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20250611", "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": "373912654", "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 THERE WAS A CONCERNING INCREASE IN SPINE SURGICAL SITE INFECTIONS (SSIS) ASSOCIATED WITH THE GUIDANCE SYSTEM ROBOT. THE INFECTION RATE HAD TRIPLED COMPARED TO FISCAL YEAR 2024, WITH SEVEN FUSION INFECTIONS REPORTED IN FY2025, FIVE OF WHICH INVOLVED PROCEDURES UTILIZING THE GUIDANCE SYSTEM ROBOT. IT WAS NOTED THAT THE INSTRUMENT WAS NOT PROPERLY CLEANED AFTER STERILIZATION, AS OBSERVED USING A BORESCOPE DOWN THE CANNULA INSERTER. IN RESPONSE TO THESE FINDINGS, THE USE OF THE GUIDANCE SYSTEM ROBOT FOR SPINE SURGERIES WAS TEMPORARILY SUSPENDED EFFECTIVE (B)(6) 2025, WHILE FURTHER INVESTIGATION AND MITIGATION EFFORTS WERE UNDERTAKEN. THE PROCEDURE BEING PERFORMED WAS AN EXPLORATION OF OCCIPUT TO C5 FUSION, REMOVAL OF HARDWARE, OCCIPUT TO C5, REVISION POSTERIOR FUSION C2-5, POSTERIOR SPINAL FUSION C6-7, T1-3, SEGMENTAL INSTRUMENTATION C3-T3, AND APPLICATION OF ALLOGRAFT BONE ON (B)(6) 2024. THE PATIENT EXPERIENCED COMPLICATIONS ON (B)(6) 2025. THE PATIENT STATED THEY EXPERIENCED WORSENING PAIN AND HARDWARE PROTRUSION 4-5 DAYS PRIOR. IT WAS NOTED THAT THE PATIENT WAS RECEIVING ABATACEPT WEEKLY. THE CLOSURE ON THE INCISION WAS PERFORMED AND B/L TRAPEZIUS MUSCLE FLAPS WERE PERFORMED BASED ON TR ANSVERSE CERVICAL AND OCCIPITAL ARTERIES AND B/L PARASPINOUS MUSCLE FLAPS BASED ON LUMBAR ARTERY AND PARASPINOUS MUSCLE PERFORATING VESSELS. BLOODY DISCHARGE WAS ALSO NOTED. THE WOUND SITE WAS CULTURED AND AEROBIC, FUNGAL, AND AFB WERE NOTED. ON (B)(6) 2025, THE PATIENT WAS POSITIVE FOR MRSA. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE PROCEDURES BEING PERFORMED WERE SACROILIAC AND THORACOLUMBAR PROCEDURES. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT MEDTRONIC FOUND NO ISSUES WITH ANY OF THE BIOLOGICS THAT WERE USED AND THE FOCUS SHIFTED TO OTHER POSSIBILITIES." }, { "mdr_text_key": "373912655", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "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": "" } ] }