{ "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": "3005075696-2021-00084", "type_of_report": [ "Initial submission", "Followup", "Followup", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20210715", "manufacturer_address_2": "", "pma_pmn_number": "K182077", "date_of_event": "20210622", "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": "20210715", "manufacturer_contact_f_name": "GLEN", "device_date_of_manufacturer": "20200618", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1068076", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20210715", "brand_name": "MAZOR X STEALTH EDITION", "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": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20210624", "device_report_product_code": "OLO", "device_age_text": "DA", "device_evaluated_by_manufacturer": "Y", "combination_product_flag": "N", "udi_di": "07290109183213", "udi_public": "07290109183213", "openfda": { "device_name": "Orthopedic Stereotaxic Instrument", "medical_specialty_description": "Neurology", "regulation_number": "882.4560", "device_class": "2" } } ], "product_problems": [ "Imprecision", "Unintended Collision", "Imprecision", "Unintended Collision" ], "reporter_state_code": "NC", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/19/2021;10/14/2021;12/03/2021;08/29/2023", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20250804", "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": "20210715", "sequence_number_treatment": [ "\"SEE H10.\"" ], "sequence_number_outcome": [ "Required Intervention", " O" ], "patient_age": "64 YR", "patient_sex": "Male", "patient_weight": "81 KG", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Muscle Weakness/Atrophy", "Nerve Damage", "Muscle Weakness/Atrophy", "Nerve Damage" ] } ], "distributor_city": "", "date_report": "20230911", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "IS", "manufacturer_contact_city": "MINNEAPOLIS", "mdr_report_key": "12173576", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20210622", "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": "327261640", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "H3: ANALYSIS OF THE SOFTWARE EXPORTS AND LOGS FOUND THE COMPLAINT WAS CONFIRMED. ANALYSIS DETERMINED THE SURGICAL ARM HITTING THE WORK VOLUME WAS RELATED TO A KNOWN SOFTWARE AND SYSTEM DEFECT. NO CLINICAL ISSUES WERE FOUND TO HAVE CONTRIBUTED TO THE DEVIATION. ANALYSIS DETERMINED THERE WAS INSUFFICIENT INFORMATION TO DETERMINE IF A SOFTWARE DEFECT CONTRIBUTED TO THE NAVIGATION BEING OFF DURING THE PROCEDURE. 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": "326727653", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: M728894B252. 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." }, { "mdr_text_key": "326727654", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE REPORTED THAT THE SURGICAL ARM HIT THE BONE MOUNT BRIDGE DURING REGISTRATION. AN AP IMAGE WAS TAKEN AND THE BRIDGE WAS HIT WHEN MOVING THE SURGICAL ARM TO THE OBLIQUE POSITION. THE 3D MARKER WAS REMOVED FROM THE ARM GUIDE PRIOR TO THE SURGICAL ARM BEING SENT TO THE OBLIQUE TRAJECTORY. A NAVIGATION ACCURACY TEST WAS DONE AFTER THE ANATOMICAL ACCURACY TEST. THE PASSIVE PLANAR PROBE WAS USED AND PLACED ON THE PATIENT'S ANATOMY AND THEN THE ARM GUIDE. ADDITIONAL ANATOMICAL CHECKS WERE DONE THROUGHOUT THE CASE SINCE AN INSTRUMENT WAS SHOWN TO BE SLIGHTLY MEDIAL DURING THE PROCEDURE. NAVIGATION ACCURACY AND GUIDANCE SYSTEM ACCURACY WERE DISCUSSED WITH THE SURGEON. THE SURGEON DECIDED TO DO ADDITIONAL SNAPSHOTS AND ACCURACY TESTS WERE PERFORMED AFTERWARDS TO AVOID RE-REGISTERING THE PATIENT. THE ADDITIONAL ANATOMICAL ACCURACY CHECKS WERE ACCURATE. THE REVISION PROCEDURE WAS COMPLETED. AFTER THE PROCEDURE, THE PATIENT STILL HAD WEAKNESS AND IMMOBILITY ON THEIR LEFT SIDE." }, { "mdr_text_key": "326050535", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: ASM0206, SERIAL/LOT #: (B)(6). 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": "336765351", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "D4, H4: THE SERIAL NUMBER OF THE SYSTEM WAS UPDATED. 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": "261708563", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: ASM0206. A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. TESTING REVEALED THAT THE SURGICAL ARM FAILED THE 3 AND 10 POINT ACCURACY CHECKS. ANALYSIS RESULTS OF THE SOFTWARE EXPORTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED." }, { "mdr_text_key": "261708564", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THERE WAS A DEVIATION DURING AN OPEN T10 TO PELVIS PROCEDURE. WHEN MOVING THE SURGICAL ARM TO A DIFFERENT TRAJECTORY DURING THE CASE, THE ARM HIT THE BONE MOUNT BRIDGE. THE SURGEON DID AN ACCURACY TEST AND EVERYTHING WAS ACCURATE. A NEW SNAPSHOT WAS DONE AS A PRECAUTION AND NAVIGATION WAS ACCURATE. A 3DEFINE SCAN WAS COMPLETED TO DEFINE THE WORK VOLUME DURING THE PROCEDURE. THE LEFT L1 SCREW WAS NOTED TO BE A LITTLE MEDIAL, BUT THE SURGEON THOUGHT THE POSITION WAS OK. AFTER THE PROCEDURE, THE PATIENT WOKE UP WITH LEFT SIDE WEAKNESS AND NO MOVEMENT IN THEIR LEFT LEG. THE SURGEON INDICATED THERE WAS SIGNIFICANT NEUROLOGICAL INJURY. A CT SCAN WAS DONE AND THE T10 - L1 SCREWS ON THE LEFT SIDE WERE ALL MEDIAL. THE MANUFACTURER REPRESENTATIVE NOTED THAT THE DEVIATIONS WERE NOT SEEN ON INTRA OP IMAGING. THE AMOUNT OF DEVIATION WAS UNKNOWN. ALL OF THE RIGHT SIDE SCREWS AND L2-PELVIS ON THE LEFT SIDE WERE PLACED ACCURATELY. THE SURGEON DID NOT FEEL THE SYSTEM WAS INACCURATE DURING THE CASE. THE SURGEON WAS STANDING ON THE LEFT SIDE OF THE PATIENT DURING THE PROCEDURE. THE CAUSE OF THE DEVIATION WAS NOT DETERMINED. A REVISION TO REPOSITION THE SCREWS WAS PLANNED. THERE PROCEDURE WAS DELAYED LESS THAN AN HOUR. THE GUIDANCE SYSTEM WAS TESTED AND THE SURGICAL ARM FAILED THE 3 AND 10 POINT ACCURACY TESTS." } ], "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": "08/11/2021;10/18/2021;12/06/2021;09/11/2023" } ] }