{ "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": "3005075696-2021-00032", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20210310", "manufacturer_address_2": "", "pma_pmn_number": "K182077", "date_of_event": "20191111", "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": [ "Foreign", "Health Professional", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "3079567", "manufacturer_g1_state": "", "reporter_country_code": "TH", "manufacturer_contact_area_code": "612", "date_added": "20210310", "manufacturer_contact_f_name": "GLEN", "device_date_of_manufacturer": "20180401", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "351594", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20210310", "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": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20210226", "device_report_product_code": "OLO", "device_age_text": "DA", "device_evaluated_by_manufacturer": "Y", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Orthopedic Stereotaxic Instrument", "medical_specialty_description": "Neurology", "regulation_number": "882.4560", "device_class": "2" } } ], "product_problems": [ "Imprecision", "Imprecision" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "12/07/2021", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20250806", "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": "20210310", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Nerve Damage", "Neuropathy", "Nerve Damage", "Neuropathy" ] } ], "distributor_city": "", "date_report": "20211209", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "IS", "manufacturer_contact_city": "MINNEAPOLIS", "mdr_report_key": "11454016", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20191111", "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": "238910296", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ANALYSIS OF THE CLINICAL EXPORTS AND LOGS WAS COMPLETED. DURING THE ANALYSIS, THE CLINICAL EXPORT DATA FILE WAS THOROUGHLY INSPECTED. THE EXPORT FILE WAS GENERATED BY THE MAZOR X SYSTEM, AND INCLUDES RECORDS OF ALL THE DATA THAT WAS USED AND GENERATED BY THE SYSTEM DURING THE CASE, INCLUDING BUT NOT LIMITED TO THE INTRA-OPERATIVE SCANS, PREOPERATIVE PLANNING, PROCEDURE ACTIONS THAT WERE EXECUTED, AND THE LOG TEXT FILE. THE LOG TEXT FILE IS A CHRONOLOGIC DOCUMENTATION OF THE SOFTWARE DURING OPERATION, INCLUDING TRAJECTORIES SENT BY THE SYSTEM, STAR MARKER (SM) RECOGNITION ACCURACY, ETC. THE LOG FILE WAS EXAMINED WITH RESPECT TO ALL INTRAOPERATIVE FLUORO IMAGES TO INSPECT AND UNDERSTAND PROCEDURE WORKFLOW. O-ARM IMAGES WERE CHECKED, STAR MARKER RECOGNITION WAS ATTEMPTED WITH THE REGISTRATION, STAR MARKER IMAGES UTILIZED DURING THE OPERATION ON A MAZOR X R<(>&<)>D WORKSTATION. ANALYSIS REVIEWED THE PLANNING MADE FOR THE CASE. THE PLANNED TRAJECTORIES OF L3 AND L4 VERTEBRAS WERE PLANNED PROUD (WIDE). AS MENTIONED IN THE CASE REPORT ¿ THE CASE PERFORMED WAS OPEN PROCEDURE. ACCORDING TO THE TRAINING MATERIAL, ¿FOR EASE OF INSTRUMENTATION AND A REDUCTION IN SOFT TISSUE FORCES, PLAN SCREWS WITH AXIAL ANGLES BETWEEN 7-12 DEGREES FOR SMALL, OPEN MIDLINE PROCEDURES.¿ THE NATURE OF THE DEVIATION WAS REVIEWED. IT WAS REPORTED THAT DURING A SCOLIOSIS CORRECTION AND POSTEROLATERAL FUSION FROM T10-L4 - A SUSPECTED BREACH AT RIGHT L4 WAS FOUND SEVERAL DAYS AFTER THE PROCEDURE. OBSERVING THE PLANNING OF L4 TRAJECTORIES FROM AP VIEW, IT IS SHOWN THAT THE PLANNED TRAJECTORIES OVERLAP WITH THE SOFT TISSUE AND ARE LOCATED LATERAL TO THE RETRACTORS. ACCORDING TO SURGICAL TECHNIQUE GUIDE IN REGARDS TO CONSTRUCTING THE SURGICAL APPROACH - INADEQUATE RETRACTION OR CONTROL OF PATIENT TISSUE(S) CAN LEAD TO DEVIATION FROM THE PLANNED/DESIRED TRAJECTORY. BY EXAMINING THE TRAJECTORIES EXECUTION ORDER, THE POSSIBILITY OF PLATFORM OR PATIENT SHIFT CAN BE RULED OUT, AS TRAJECTORIES EXECUTED BEFORE AND AFTER DEVIATED ONE WERE ACCURATE. NOT ELIMINATING THE SUB-OPTIMAL PLANNING FOR L3 AND L4 TRAJECTORIES, ANALYSIS REVIEWED ALL AVAILABLE INFORMATION AND CONCLUDED THE ROOT CAUSE OF THE DEVIATION OF L4 RIGHT IS SOFT-TISSUE PRESSURE APPLIED ON THE TOOLS WHILE INSTRUMENTING, RESULTED IN MEDIALLY DEVIATED L4 RIGHT TRAJECTORY. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED." }, { "mdr_text_key": "238910297", "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 WERE TECHNICAL ISSUES DURING A SCOLIOSIS CORRECTION AND POSTEROLATERAL FUSION FROM T10-L4. THE GUIDANCE SYSTEM WAS INACCURATE AND A SUSPECTED BREACH AT RIGHT L4 WAS FOUND SEVERAL DAYS AFTER THE PROCEDURE. THE AMOUNT OF INACCURACY WAS UNKNOWN. NO TROUBLESHOOTING WAS DONE DURING THE INITIAL PROCEDURE AS THE INACCURACY OCCURRED ON THE LAST LEVEL AND THE SURGEON DECIDED TO NOT READJUST THE SCREW. THE REPRESENTATIVE SUSPECTED POSSIBLE SOFT TISSUE PULLING AS THE INACCURACY OCCURRED DURING THE LAST LEVEL. THE PATIENT EXPERIENCED CHRONIC NEUROPATHIC LEG PAIN. NOTHING WAS NOTICED ON THE POST-OP SPIN, BUT A CT SCAN FOUND THE SCREWS WERE PLACED TOO CLOSE TO THE NERVES. A BALL STIMULATING PROBE WAS USED TO CHECK EMB CHANGES AT L4. THERE WERE NO CHANGES, EVEN AT THE HIGHEST STIMULATION. A REVISION PROCEDURE WAS DONE TO REMOVE THE SCREWS AND PLACE NEW ONES. THE PROCEDURE WAS DELAYED LESS THAN AN HOUR." }, { "mdr_text_key": "327076816", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "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": "12/09/2021" } ] }