{ "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": "3005075696-2020-00142", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20201207", "manufacturer_address_2": "", "pma_pmn_number": "K182077", "date_of_event": "20201112", "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": "20201207", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1423020", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20201207", "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": "20201120", "device_report_product_code": "OLO", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "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": [ "Use of Device Problem", "Use of Device Problem" ], "reporter_state_code": "ID", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "12/10/2020", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250811", "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": "20201207", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "66 YR", "patient_sex": "", "patient_weight": "109", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Pain", "Pain" ] } ], "distributor_city": "", "date_report": "20210107", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10959916", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20201112", "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": "321944391", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "H3: ANALYSIS OF THE SOFTWARE 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. FLUORO 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 (REGISTRATION). THE CT-FLUORO MATCHING OF THE VERTEBRAE WERE DETERMINED ACCEPTABLE. AS REPORTED, L3 RIGHT VERTEBRA WAS REPORTED WITH MEDIAL DEVIATION, BY EXAMINING THE PLANNING MADE ON L3 VERTEBRA, IT CAN BE SEEN THAT ONLY THE RIGHT TRAJECTORY HAD DEVIATED MEDIALLY COMPARED TO THE PLAN. THE MOUNTING PLATFORM USED WAS A SCHANZ SCREW TO THE RIGHT PSIS IN AN OPEN CASE. GUIDELINES WHEN USING SCHANZ SCREW IN AN OPEN CASE SURGERY CAN GUARANTEE STABILITY AND ACCURACY FROM SACRAL VERTEBRA S2 UP TO LUMBAR L4. USING THE FIXATION SYSTEM OUTSIDE ITS OFFICIAL GUIDELINES AND APPROVED BOUNDARIES CANNOT ASSURE ITS RELIABILITY AND MAY LEAD TO INSTABILITY OF THE SURGICAL SYSTEM, PLATFORM SHIFT, DEVIATION AND INJURY. ANALYSIS REVIEWED ALL AVAILABLE INFORMATION AND CONCLUDED THE ROOT CAUSE OF THE MEDIAL DEVIATION AND BREACH TO BE INADEQUATE FIXATION PLATFORM, MOST PROBABLY LEADING TO A PLATFORM SHIFT AFTER INSTRUMENTING L3 RIGHT. 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": "321944392", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE REPORTED THAT THE SCREW WAS MISPLACED BY 1 CM." }, { "mdr_text_key": "219948930", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ANALYSIS RESULTS 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": "219948931", "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 DEGENERATIVE DISCS WITH FIXATION. IT WAS REPORTED THAT DURING AN OPEN CASE, AN XLIF WAS COMPLETED FIRST. THE PATIENT WAS THEN FLIPPED AND THE OPEN INCISION WAS MADE. REGISTRATION WAS SUCCESSFULLY COMPLETED WITH 2 AP AND ONE OBLIQUE IMAGES. THE SURGEON USED THE GUIDANCE SYSTEM TO PLACE SCREWS AT L3. HARDWARE AT L4 AND L5 WAS REPLACED AND S1 WAS REMOVED. RIGHT L3 WAS DEVIATED MEDIALLY DUE TO SOFT TISSUE PRESSURE. LEFT L3 WAS ACCURATE. PRIOR TO THE CASE, THE SYSTEM PASSED A SETUP TEST. POST OP IMAGES WERE TAKEN AND THE SURGEON FELT THE PLACEMENT WAS GOOD; HOWEVER, THE PATIENT HAD PAIN WHEN THEY WOKE UP. A REVISION WAS DONE ON THE FOLLOWING DAY. THE SCREW WAS REPOSITIONED FREEHAND. THE INITIAL 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": "01/07/2021" } ] }