{ "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": "P.O. BOX 3104", "event_location": "", "report_to_fda": "", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "MN", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "7000 CENTRAL AVENUE NE RCW215", "manufacturer_g1_city": "CAESAREA HEFA,IL", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "61227132", "event_type": "Injury", "report_number": "3005075696-2022-00065", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20220915", "manufacturer_address_2": "", "pma_pmn_number": "K182077", "date_of_event": "20220817", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "55432", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "6122713209", "noe_summarized": "1", "manufacturer_contact_l_name": "BELMER", "source_type": [ "Health Professional", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "3079567", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "612", "date_added": "20220915", "manufacturer_contact_f_name": "GLEN", "device_date_of_manufacturer": "20211219", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2522341", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20220915", "brand_name": "MAZOR X SYSTEM", "generic_name": "ORTHOPEDIC STEREOTAXIC INSTRUMENT", "manufacturer_d_name": "MAZOR ROBOTICS LTD", "manufacturer_d_address_1": "5 SHACHAM STREET", "manufacturer_d_address_2": "P.O. BOX 3104", "manufacturer_d_city": "CAESAREA HEFA,IL", "manufacturer_d_state": "", "manufacturer_d_zip_code": "30795", "manufacturer_d_zip_code_ext": "67", "manufacturer_d_country": "IS", "manufacturer_d_postal_code": "3079567", "device_operator": "HEALTH PROFESSIONAL", "model_number": "TPL0059", "catalog_number": "TPL0059", "lot_number": "", "other_id_number": "", "device_availability": "No", "date_returned_to_manufacturer": "20220907", "device_report_product_code": "OLO", "device_age_text": "DA", "device_evaluated_by_manufacturer": "Y", "combination_product_flag": "N", "udi_di": "07290109184838", "udi_public": "07290109184838", "openfda": { "device_name": "Orthopedic Stereotaxic Instrument", "medical_specialty_description": "Neurology", "regulation_number": "882.4560", "device_class": "2" } } ], "product_problems": [ "Unintended Application Program Shut Down", "Unintended Application Program Shut Down" ], "reporter_state_code": "OH", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "09/16/2022", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20250807", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "67", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "6122", "patient": [ { "patient_sequence_number": "1", "date_received": "20220915", "sequence_number_treatment": [ "\"SEE H10....\"" ], "sequence_number_outcome": [ "Other" ], "patient_age": "", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Clinical Signs, Symptoms or Conditions", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20220920", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "IS", "manufacturer_contact_city": "MINNEAPOLIS", "mdr_report_key": "15426822", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20220817", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "30795", "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": "299942986", "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 THE SCREENS ON THE SYSTEM WENT BLACK TWICE BEFORE THE 3 DEFINE SCAN WAS COMPLETED. THE SCREEN WENT BLACK FOR ABOUT 90 SECONDS, AND ALL INSTRUMENTS WOULD HAVE TO BE REVERIFIED AFTER EACH INSTANCE. THE CODES REMAINED. THE SYSTEM WAS DELAYED BY TEN MINUTES. THE SURGEON PLANNED ON INSERTING FOUR SCREWS, BUT THE ANESTHESIOLOGIST ABORTED THE SURGERY DUE TO THE PATIENT'S HIGH BLOOD PRESSURE AFTER TWO SCREWS WERE INSERTED.  THE THIRD SCREW WAS IN THE PROCESS OF BEING INSERTED WHEN THE SURGERY WAS ABORTED. THE MANUFACTURE REPRESENTATIVE BELIEVED THE ENTIRE SURGERY WOULD HAVE BEEN COMPLETED HAD THE SITE NOT FACED DELAYS. THERE WAS NO FURTHER PATIENT HARM REPORTED." }, { "mdr_text_key": "299942987", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "CONTINUATION OF CONCOMITANT MEDICAL PRODUCTS: THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID:: ASM0357, SERIAL/LOT : UNKNOWN. THE PATIENT AND SURGEON INFORMATION HAVE BEEN REQUESTED, BUT ARE UNAVAILABLE AT THE TIME OF THIS REPORT. A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO PERFORM A SYSTEM CHECK OUT AND THEY REPLACED THE SURGEON SCREEN WITH THE ARM. THE SYSTEM FUNCTIONED AS INTENDED. ADVERSE EVENT OR PRODUCT PROBLEM, AND COMMON DEVICE NAME ARE APPLICABLE TO THE SYSTEM CHECKOUT. THE SURGEON SCREEN AND ARM WERE RETURNED FOR PRODUCT ANALYSIS. THE ANALYSIS IS STILL IN PROGRESS. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED." }, { "mdr_text_key": "331883809", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "H3: HARDWARE ANALYSIS CONCLUDED THAT THERE WAS A CONFIRMED ELECTRICAL FAILURE WITH THE SURGICAL SCREEN WITH THE ARM. THERE WAS NO DISPLAY OUTPUT. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "5 SHACHAM STREET", "distributor_zip_code": "", "manufacturer_contact_postal_code": "55432", "manufacturer_contact_exchange": "612", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "09/20/2022" } ] }