{ "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": "3005075696-2025-00275", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20250606", "manufacturer_address_2": "", "pma_pmn_number": "K182077", "date_of_event": "20241202", "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", "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": "20250606", "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": "2129763", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20250606", "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": "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": "06/17/2025", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20250826", "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": "20250606", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention", " O", " H" ], "patient_age": "57 YR", "patient_sex": "Female", "patient_weight": "124 KG", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Bacterial Infection", "Seroma", "Post Operative Wound Infection", "Unspecified Tissue Injury", "Bacterial Infection", "Seroma", "Post Operative Wound Infection", "Unspecified Tissue Injury" ] } ], "distributor_city": "", "date_report": "20250707", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "IS", "manufacturer_contact_city": "MOUNDS VIEW", "mdr_report_key": "22158848", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20250508", "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": "371863835", "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." }, { "mdr_text_key": "371863836", "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 MAY 19, 2025, WHILE FURTHER INVESTIGATION AND MITIGATION EFFORTS WERE UNDERTAKEN. 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": "376913893", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "H2) ADDITIONAL INFORMATION IN SECTIONS A AND B. 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": "376913894", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "THE PROCEDURE BEING PERFORMED WAS A POSTERIOR LUMBAR SURGERY. THE PATIENT EXPERIENCED DIFFICULTIES BEGINNING ON (B)(6) 2024 WITH COMPLAINTS OF PAIN AND DRAINAGE FROM THE SURGICAL WOUND. THE PATENT DID NOT EXPERIENCE FEVER AND THEIR WHITE BLOOD CELL COUNT WAS NOTED AS 11.0 ON (B)(6) 2024. AS PER REOPERATION ON (B)(6) 2024, THE POST INCISION SPINAL WOUNDS WERE OPEN AND FLUID WAS LEAKING ONTO THE SURGICAL DRESSINGS. THERE WAS NO PURULENT MATERIAL ENCOUNTERED, BUT RED SEROMA TYPE FLUID WAS SENT FOR CULTURE AND EXAMINATION. THE PATIENT WAS HOSPITALIZED (B)(6) 2024 TO (B)(6) 2024. ADDITIONAL SURGERY INCLUDED COMBINATION PLASTIC SURGERY COMPLEX WOUND CLOSURE WITH VACUUM ASSISTED PRESSURE DRESSING, IRRIGATION, DEBRIDEMENT, AND CULTURE ASPIRATION SAMPLE. ON (B)(6) 2024, STAPHYLOCOCCUS EPIDERMIDIS WAS PRESENT. IT WAS NOTED THERE WAS NO FUNGAL GROWTH. AS OF (B)(6) 2024, THE PATIENT WAS DISCHARGED HOME IN STABLE CONDITION WITH HOME HEALTH CARE." } ], "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": "07/07/2025" } ] }