{ "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": "", "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": "3005075696-2026-00086", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20260414", "manufacturer_address_2": "", "pma_pmn_number": "K230064", "date_of_event": "20260320", "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": "SZ", "manufacturer_contact_area_code": "", "date_added": "20260414", "manufacturer_contact_f_name": "JUSTIN", "device_date_of_manufacturer": "20250702", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "934276", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20260414", "brand_name": "MAZOR X SYSTEM", "generic_name": "ORTHOPEDIC STEREOTAXIC INSTRUMENT", "manufacturer_d_name": "MAZOR ROBOTICS LTD", "manufacturer_d_address_1": "1 HAESHEL STREET. (BUILDING C)", "manufacturer_d_address_2": "CAESAREA BUSINESS PARK", "manufacturer_d_city": "CAESAREA HEFA,IL", "manufacturer_d_state": "", "manufacturer_d_zip_code": "30798", "manufacturer_d_zip_code_ext": "30", "manufacturer_d_country": "IS", "manufacturer_d_postal_code": "3079830", "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": "20260327", "device_report_product_code": "OLO", "device_age_text": "DA", "device_evaluated_by_manufacturer": "Y", "combination_product_flag": "N", "udi_di": "07290115751895", "udi_public": "(01)07290115751895(11)250702", "openfda": { "device_name": "Orthopedic Stereotaxic Instrument", "medical_specialty_description": "Neurology", "regulation_number": "882.4560", "device_class": "2" } } ], "product_problems": [ "Incorrect, Inadequate or Imprecise Result or Readings" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "04/22/2026;07/06/2026", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20260714", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "30", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20260414", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "17 YR", "patient_sex": "Male", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Cerebrospinal Fluid Leakage", "Ambulation or Postural Difficulties" ] } ], "distributor_city": "", "date_report": "20260714", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "IS", "manufacturer_contact_city": "MOUNDS VIEW", "mdr_report_key": "24877325", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20260320", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "30798", "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": "398418696", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED IN TWO SEGMENTS. THE SURGEON CREATED THE PLANNING INDEPENDENTLY AND INDICATED THAT THE TRAJECTORIES PROVIDED WERE MORE MEDIAL THAN IF THEY WERE TO FREEHAND, BUT CHOSE TO EXECUTE THE PLAN. T9-L1 SEGMENT WAS PERFORMED WITHOUT ISSUE. DURING THE SECOND SEGMENT, T4-T8, ALL SCREW ON THE LEFT WERE COMPLETED WITHOUT ISSUE. THE MANUFACTURER REPRESENTATIVE RECOMMENDED A REFERENCE FRAME ON A SPINOUS PROCESS CLAMP FOR NAVIGATIONAL ACCURACY, BUT THE SURGEON REFUSED CITING SPACE IN THE OPERATIVE FIELD. RIGHT T8 WAS EXECUTED WITHOUT AN ISSUE, BUT DURING RIGHT T6, THE SURGEON REPORTED A POSSIBLE COLLISION BETWEEN SCREW AND MOUNT, BUT ACCURACY WAS CONFIRMED. AT RIGHT T4, THERE WAS AN AUDIBLE CHANGE IN PITCH INDICATING THAT THE DRILL HAD EXITED AND RE-ENTERED THE CORTICAL BONE DURING DRILLING. WHEN THE DRILL WAS REMOVED A SIGNIFICANT CSF LEAK WAS OBSERVED. THE GUIDANCE SYSTEM WAS UNMOUNTED AND A SCAN SHOWED THAT RIGHT T4 AND T6 WERE MEDIAL. THESE SCREWS WERE REPLACED WITH NAVIGATION. A MOTOR CHECK FOUND WEAKNESS TO THE RIGHT SIDE, REQUIRING INCREASED STIMULATION. THE ANAESTHETIC TEAM REPORTED NO MOVEMENT OF THE PATIENT OR COUGHING. IMAGING CONFIRMED NO OBSERVABLE SPINAL CORD INJURIES. THE PATIENT HAD NO VOLUNTARY MOTION TO THE RIGHT LEG 24 HOURS AFTER THE SURGERY. THIS IMPROVED WITH SOME VOLUNTARY CONTRACTIONS LESS THAN 72 HOURS AFTER THE SURGERY. THE SURGERY WAS ABANDONED UNTIL NEUROLOGICAL SYSTEM RESOLVE. ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE REPORTED THAT TWO TRAJECTORIES WERE DEEMED TO BE DEVIATED BOTH LESS THAN 3.5 MM. THERE WAS BONEY REMOVAL OCCURRED AT EACH TRAJECTORY, IN ORDER TO REDUCE SKIVE POTENTIAL AND PROVIDING ADDITIONAL FUSION POTENTIAL. THE SURGEON OPTED TO NOT TAP FOR SOME SCREWS, BUT TAPPED A FEW TRAJECTORIES WHEN THEY FOUND THE SCREW TIP WOULDN'T ENGAGE INTO THE DRILL ENTRY POINT. TWO SURGEON OPERATED, WORKING ON THE SIDE THEY WERE STANDING. RIGHT SIDE WAS BEING PERFORMED BY A MORE JUNIOR SURGEON, WHICH HAD ACCESS LIMITATIONS DUE TO THE AXIAL ROTATION." }, { "mdr_text_key": "398418697", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "H3, H6: THE EXPORTS/LOGS WERE RETURNED FOR CLINICAL ANALYSIS. THE ANALYSIS IS STILL IN PROGRESS. MULTIPLE PATIENT CODES WERE APPLIED. BELOW CLARIFIES WHAT EACH IS ASSOCIATED WITH. E0106 - CSF LEAK E2302 - NO VOLUNTARY MOTION TO THE RIGHT LEVEL 24 HOURS AFTER THE SURGERY 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": "05/14/2026;07/14/2026" } ] }