{ "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": "3005075696-2024-00080", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20240718", "manufacturer_address_2": "", "pma_pmn_number": "K230064", "date_of_event": "20240702", "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": [ "Health Professional", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "3079830", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "763", "date_added": "20240718", "manufacturer_contact_f_name": "JUSTIN", "device_date_of_manufacturer": "20230626", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1552486", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20240718", "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": "20240703", "device_report_product_code": "OLO", "device_age_text": "", "device_evaluated_by_manufacturer": "Y", "combination_product_flag": "N", "udi_di": "07290115751376", "udi_public": "07290115751376", "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", "Use of Device Problem", "Incorrect, Inadequate or Imprecise Result or Readings", "Use of Device Problem" ], "reporter_state_code": "NY", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20250820", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "30", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "7635", "patient": [ { "patient_sequence_number": "1", "date_received": "20240718", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other", " R" ], "patient_age": "57 YR", "patient_sex": "Female", "patient_weight": "77 KG", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Unspecified Nervous System Problem", "Unspecified Nervous System Problem" ] } ], "distributor_city": "", "date_report": "20240718", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "IS", "manufacturer_contact_city": "MOUNDS VIEW", "mdr_report_key": "19772971", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20240702", "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": "347190016", "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 DURING A REVISION OF T7 TO L2, WITH AN EXTENSION OF FUSION FROM T4 TO T7, USING A \"UNID\" ROD USING THE CT TO FLUORO WORKFLOW, THERE WAS AN ALLEGED INACCURACY. AFTER DISCUSSING THE CASE WITH THE SURGEON, IT WAS DECIDED THAT THEY WOULD BE PLACING SCREWS IN T4, T5, AND T6, AND REMOVING THE EXISTING HARDWARE AT T7 AND T8 AND REDIRECTING AND REPLACING THE SCREWS AT T7 AND T8. WHILE REGISTERING THE PATIENT TO THE ROBOTIC SYSTEM, THEY HAD GOTTEN SEGMENTATION ON THEIR FIRST AP AND OBLIQUE SHOTS, BUT WHEN IT WENT TO THE REGISTRATION, THEY GOT RED VALUES AT ALL LEVELS (T4-T8). THEY ADJUSTED THE NON-MEDTRONIC IMAGING SYSTEM AND TOOK A NEW OBLIQUE IMAGE AND THEY WERE ABLE TO GET SEGMENTATION AND GREEN VALUES ON THE SECOND REGISTRATION ATTEMPT. THEY CHECKED FOR SHIFTS AND NONE WERE NOTED SO THEY PROCEEDED TO THE OPERATE PORTION. THEY STARTED WITH T4 ON THE RIGHT AND WORKED THEIR WAY DOWN THE RIGHT SIDE, PLACING SCREWS IN T4, T5, AND T6. THE NEUROMONITORING TEAM RAN A MOTOR TEST AFTER THEY PUT IN THE 3 SCREWS ON THE RIGHT SIDE AND THERE WERE NO CHANGES. THE SITE THEN SWITCHED TO THE LEFT SIDE OF THE PATIENT AND STARTED AT T4 AND WORKED DOWN TO T6. WHILE WATCHING THE NAVIGATION AND TAPING THE HOLE FOR T5 ON THE LEFT, IT WAS NOTICED THAT THE TAP LOOKED LIKE IT WAS DRIFTING MEDIAL ON THE NAVIGATION. THE SURGEON WAS INSTRUCTED TO STOP AND REMOVE THE TAP AND CHECK THE HOLE WITH A PEDICLE PROBE. THE SURGEON STATED THAT THE HOLE FELT FINE AND THEN PROCEEDED TO PLACE THE SCREW AT T5 ON THE LEFT. NEUROMONITORING THEN RAN ANOTHER MOTOR AFTER THE T6 SCREW ON THE LEFT, AND NOTICED A DEFICIT ON THE LEFT SIDE, STATING THAT THEY LOST MOTORS ON THE LEFT SIDE. THEY BROUGHT IN THE NON-MEDTRONIC IMAGING SYSTEM TO LOOK AT THE POSITION OF THE SCREWS AND THEY FELT LIKE THE SCREWS APPEARED TO BE IN AN ACCEPTABLE POSITION SO THEY CONTINUED WITH REMOVING THE EXISTING SCREWS AT T7 AND T8. THE SITE RE-POSITIONED THE SCREWS USING THE MEDTRONIC ROBOTIC GUIDANCE SYSTEM. THE SURGEON THEN ASKED TO HAVE THE MEDTRONIC IMAGING SYSTEM COME IN AND DO A SPIN TO CHECK ALL THE SCREWS PLACED. THIS IS WHEN IT WAS NOTICED THAT THE 6 SCREWS PLACED AT T4, T5, AND T6 WERE ALL APPROXIMATELY 3 MILLIMETERS (MM) MEDIAL TO THE PLAN, CAUSING A BREACH TO THE MEDIAL CORTEX OF THE PEDICLE BILATERALLY. THE SCREWS PLACED IN T7 AND T8 WERE PLACED ACCORDING TO THE PLAN. THE SURGEON THEN ABORTED THE MEDTRONIC ROBOTIC GUIDANCE SYSTEM AND CALLED FOR A MEDTRONIC NAVIGATION SYSTEM TO REPOSITION THE MISPLACED SCREWS AT T4, T5, AND T6. AFTER REPOSITIONING THE SCREWS USING THE MEDTRONIC NAVIGATION SYSTEM, NEUROMONITORING STATED THAT THEY WERE STARTING TO GET SOME INTERMITTENT RESPONSES IN THE MOTORS ON THE LEFT SIDE. IT WAS REPORTED THAT THE PATIENT WAS AFFECTED AND SURGICAL DELAY WAS REPORTED AS LONGER THAN ONE-HOUR. AFTER THE PROCEDURE THE PATIENT WAS DOING GOOD AND WAS NOT SHOWING ANY DEFICITS." }, { "mdr_text_key": "347190017", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO PERFORM A SYSTEM CHECK OUT AND THEY FOUND THAT THE SYSTEM FUNCTIONED AS INTENDED. NO PROBLEMS WERE DETECTED. THE EXPORTS WERE PROVIDED FOR CLINICAL ANALYSIS. THE ANALYSIS DETERMINED THAT THE MEDIAL DEVIATIONS RESULTED FROM A COMBINATION OF SOFT TISSUE PRESSURE APPLIED TO THE TOOLS DURING INSTRUMENTATION, ALONG WITH MEDIAL SIEVING POTENTIAL OBSERVED IN THE PLAN AND HIGH AXIAL ANGLES. THE RISK OF MECHANICAL PRESSURE APPLIED TO A GUIDED SURGICAL INSTRUMENT CAUSING A DEVIATION FROM THE PLANNED OR DESIRED TRAJECTORY IS COVERED UNDER RISK-61514, DHF0504-01_0361. THE RISK OF SKIVING OF SURGICAL ACCESSORIES IS COVERED UNDER RISK-62215, DHF0504-01_0304. B01, C13, D11 ARE APPLICABLE TO THE CLINICAL ANALYSIS. MULTIPLE DEVICE CODES WERE APPLIED. BELOW IS WHAT EACH IS ASSOCIATED WITH. A0908 - INACCURACY A23 - REGISTRATION ISSUE. 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": "763", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }