{ "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": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "3005075696-2021-00012", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20210120", "manufacturer_address_2": "", "pma_pmn_number": "K182077", "date_of_event": "20201229", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "COMPANY REPRESENTATIVE", "HEALTH" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20210120", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "101195", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20210120", "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": "20210115", "device_report_product_code": "OLO", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "07290109180465", "udi_public": "07290109180465", "openfda": { "device_name": "Orthopedic Stereotaxic Instrument", "medical_specialty_description": "Neurology", "regulation_number": "882.4560", "device_class": "2" } } ], "product_problems": [ "Imprecision", "Imprecision" ], "reporter_state_code": "FL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "01/21/2021;03/21/2021", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250815", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20210120", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "25 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Clinical Signs, Symptoms or Conditions", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20210323", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "11201419", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20201229", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "322165293", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS NOTED THAT THE L1 SCREW WAS 4.5MM MEDIAL AND THE L2 SCREW WAS 1.5-2MM LATERAL. THE L2 SCREW WAS NOT REDIRECTED OR REVISED. NO PERMANENT HARM WAS DONE TO THE PATIENT DUE TO THE DEVIATIONS." }, { "mdr_text_key": "322165294", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "H3: A MANUFACTURER REPRESENTATIVE WENT TO THE SITE TO TEST THE SYSTEM. TESTING FOUND NO FAULT WITH THE SYSTEM. SYSTEM WAS ACCURATE AND FULLY FUNCTIONAL. ANALYSIS RESULTS OF THE EXPORT AND LOGS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE. 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": "322172902", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "H3: ANALYSIS OF THE EXPORTS AND LOGS WAS COMPLETED. CLINICAL EXPORT DATA FILE WAS THOROUGHLY INSPECTED. THE LOG FILE WAS EXAMINED WITH RESPECT TO ALL INTRAOPERATIVE FLUORO IMAGES IN ORDER TO INSPECT AND UNDERSTAND PROCEDURE WORKFLOW. FLUOROSCOPIC IMAGES WERE CHECKED, AND 3D REGISTRATION WAS ATTEMPTED WITH THE REGISTRATION 3D MARKER IMAGES UTILIZED DURING THE OPERATION ON A MAZOR X R & D WORKSTATION. ANALYSIS REVIEWED THE PLANNING MADE FOR THE CASE. NO ISSUES WERE FOUND WITH THE PLANNED TRAJECTORIES. ANALYSIS REVIEWED THE MATCHING ACCURACY OF THE SYSTEM AND THE CT-FLUORO MATCHING OF THE VERTEBRAE WERE DETERMINED ACCEPTABLE. IT WAS REPORTED THAT DURING A L1-S1 OPEN TRAUMA CASE, L1 RIGHT WAS DEVIATED MEDIALLY WHILE L2 LEFT DEVIATED LATERALLY. NO POST OP DEVIATION IMAGES WERE PROVIDED. THE FIXATION PLATFORM USED WAS A SCHANZ SCREW WITH SCHANZ PIN CONNECTED TO BONE MOUNT BRIDGE IN THE RIGHT PSIS. ACCORDING TO THE SURGICAL TECHNIQUE GUIDE, WHEN USING A SCHANZ SCREW IN AN OPEN CASE, THE APPROVED OPERATIONAL RANGE IS FROM S2 TO L4. FURTHERMORE, IT WAS MENTIONED THAT L2, L3 AND L4 VERTEBRAS WERE FRACTURED AND COULD CONTRIBUTE TO INSTABILITY OF THE ANATOMY. ANALYSIS REVIEWED ALL AVAILABLE INFORMATION AND CONCLUDED THE ROOT CAUSE OF THE DEVIATIONS TO BE INADEQUATE FIXATION PLATFORM, MOST PROBABLY LEADING TO A PLATFORM SHIFT WHEN INSTRUMENTING L1, L2 AND L3 THAT WERE OUT OF THE SAFE OPERATIONAL RANGE RECOMMENDED WHEN USING SCHANZ SCREW AND SCHANZ ARM. THE FRACTURED VERTEBRAS (L2-L4) MAY HAVE ALSO CONTRIBUTED TO THE INSTABILITY OF THE SYSTEM. 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": "227755930", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. TESTING REVEALED THAT THE SYSTEM WAS WORKING AS INTENDED. THE SUSPECTED CAUSE WAS RELATED TO PLANNING AND EXECUTION OF THE TRAJECTORIES DURING THE PROCEDURE. THE SYSTEM THEN PASSED THE SYSTEM CHECKOUT AND WAS FOUND TO BE FULLY FUNCTIONAL. ANALYSIS RESULTS OF THE EXPORT AND LOGS 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": "227755931", "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 TO TREAT TRAUMA WITH FIXATION. IT WAS REPORTED THAT DURING A L1-S1 TRAUMA CASE, THE LEFT L2 SCREW DEVIATED IN THE LATERAL DIRECTION AND THE RIGHT L1 SCREW DEVIATED IN THE MEDIAL DIRECTION. TWO SCHANZ ARMS WERE PLACED IN THE PSIS TO MOUNT THE SURGICAL SYSTEM TO THE PATIENT. A DUAL CLAMP WAS RECOMMENDED, BUT THE SURGEON DECIDED TO USE THE SCHANZ ARMS. THE MANUFACTURER REPRESENTATIVE NOTED THAT THERE WERE FRACTURES AT L2, L3 AND L4 WHICH COULD HAVE CAUSED THE VERTEBRAL BODIES TO SHIFT. THE REPRESENTATIVE BELIEVED THE DEVIATIONS WERE DUE TO THE CHOICE OF PLATFORM. AT EACH TRAJECTORY, THE SURGEON DRILLED THE PILOT HOLE, PLACED THE K-WIRE, TAPPED AND PLACED THE SCREW BEFORE MOVING TO THE NEXT TRAJECTORY. A REVISION TO REPOSITION THE SCREWS WAS COMPLETED ON (B)(6) 2021. THE REPRESENTATIVE MENTIONED THE GUIDANCE SYSTEM HAD BEEN USED MULTIPLE TIME SINCE THE PROCEDURE WITHOUT ISSUE. THERE WAS NO PATIENT HARM AND THE PROCEDURE WAS DELAYED LESS THAN AN HOUR." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "02/10/2021;03/23/2021" } ] }