{ "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": "CAESAREA BUSINESS PARK", "event_location": "", "report_to_fda": "N", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "MN", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "8200 CORAL SEA STREET NE MVS21", "manufacturer_g1_city": "CAESAREA HEFA,IL", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "76352656", "event_type": "Injury", "report_number": "3005075696-2026-00108", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20260623", "manufacturer_address_2": "", "pma_pmn_number": "K230064", "date_of_event": "20260616", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "55112", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "7635265677", "noe_summarized": "1", "manufacturer_contact_l_name": "ELLIS", "source_type": [ "Foreign", "Health Professional", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "3079830", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20260623", "manufacturer_contact_f_name": "JUSTIN", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "517917", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20260623", "brand_name": "MAZOR X SYSTEM", "generic_name": "ORTHOPEDIC STEREOTAXIC INSTRUMENT", "manufacturer_d_name": "MAZOR ROBOTICS LTD", "manufacturer_d_address_1": "1 HAESHEL STREET. 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IT WAS REPORTED THAT DURING A TLIF PROCEDURE FROM L4-S1, THE SCHANZ ARM AND SCREW WERE USED TO AFFIX THE ROBOT TO THE PSIS. THE REGISTRATION WAS PERFORMED. RETRACTORS WERE REMOVED PRIOR TO THE SCAN AND REINTRODUCED BEFORE INSTRUMENTATION. THE SURGEON NOTICED THE INACCURACY WITH THE ROBOTIC TRAJECTORY NOTING THE DEVIATIONS ON L5 VERTABRAE WERE BOTH MEDIAL TOWARDS SPINAL CANAL. THE DEVIATION WAS OVER 5 MM AND BETWEEN 3.5-10 MILLIMETERS (MM). THE VERTEBRAL WALLS WERE BREACHED AND A DURAL TEAR OCCURRED. THE SURGEON TOOK CORRECTIVE ACTION AND REPAIRED THE DURAL TEAR. THE GUIDANCE SYSTEM WAS ABORTED AND NAVIGATION WAS USED TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS DELAYED LESS THAN AN HOUR. UPON FOLLOW-UP WITH SURGEON, PATIENT NOW COMPLAINED OF RIGHT LEG PAIN." }, { "mdr_text_key": "405346850", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "H3, H6: NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. CODES B17, C20, AND D15 ARE APPLICABLE TO THIS ANALYSIS. A1-A4 PATIENT INFORMATION UNAVAILABLE. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN." }, { "mdr_text_key": "15580576905", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "Additional information received from a manufacturer representative reported that the suspected cause was a technique error. The site believed soft tissue pressure caused the robotic arm deviation from the predefined trajectories." }, { "mdr_text_key": "16080576906", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "See B5. H3, H6: The exports/logs were returned for clinical analysis. The analysis is still in progress. Medtronic submits this report to comply with FDA regulations 21 CFR Parts 4 and 803. Medtronic has made reasonable efforts to provide 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. Any required fields that are unpopulated are blank because the information is currently unknown or unavailable. Medtronic will submit a supplemental report if additional relevant information becomes known." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "1 HAESHEL STREET. (BUILDING C)", "distributor_zip_code": "", "manufacturer_contact_postal_code": "55112", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "08/26/2026" } ] }