{ "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": "3005075696-2024-00150", "type_of_report": [ "Initial submission", "Followup", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20241104", "manufacturer_address_2": "", "pma_pmn_number": "K182077", "date_of_event": "20241009", "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": "20241104", "manufacturer_contact_f_name": "JUSTIN", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2188991", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20241104", "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": "No", "device_report_product_code": "OLO", "device_age_text": "DA", "device_evaluated_by_manufacturer": "N", "combination_product_flag": "N", "udi_di": "07290109183213", "udi_public": "07290109183213", "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", "Incorrect, Inadequate or Imprecise Result or Readings" ], "reporter_state_code": "AR", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "11/13/2024;12/16/2024;02/10/2025", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20250821", "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": "20241104", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "75 YR", "patient_sex": "Male", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Dural Tear", "Nerve Damage", "No Clinical Signs, Symptoms or Conditions", "Dural Tear", "Nerve Damage", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20250212", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "IS", "manufacturer_contact_city": "MOUNDS VIEW", "mdr_report_key": "20599582", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20241009", "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": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "N", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "359870617", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE REPORTED THAT THE DEVIATION AMOUNT WAS AROUND 3 MILLIMETERS (MM)." }, { "mdr_text_key": "359870618", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "H2) ADDITIONAL INFORMATION IN SECTIONS A AND B5. 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": "364135426", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "A3: PATIENT NAME, AGE/DOB, AND SEX WAS CLARIFIED/PROVIDED. H1: SERIOUS INJURY WAS REPORTED. H6: THERE ARE MULTIPLE PATIENT CODES. CLARIFICATION IS PROVIDED BELOW. E0123 - NERVE DAMAGE. E0144 - DURAL TEAR. 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": "364135427", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE SURGEON WAS WORRIED ABOUT THE PEDICLE SCREW AT LEFT L3, SO THEY REMOVED MORE BONE AND TISSUE AND IDENTIFIED MORE OF THE ORIGIN OF THE NERVE. IT WAS FOUND THAT THERE WAS METAL. THE SCREW WAS REMOVED, AND IT WAS FOUND THAT A TEAR AT THE PROXIMAL PORTION OF THE NERVE ORIGIN. THE SCREW HAD GONE THROUGH IT, AND LEFT A HOLE THAT WAS SEVERAL MILLIMETERS THROUGH IT. THE RIGHT L3 SCREW WAS REMOVED, AND THE NERVE WAS INTACT. THERE WAS A LITTLE RENT IN THE SIDE OF THE DURA, NEAR THE AXILLA, BIT THE NERVE WAS MORE OR LESS INTACT. WITH NAVIGATION THE SCREWS WERE REPLACED FOR LEFT AND RIGHT L3 WITH NO FURTHER INJURY." }, { "mdr_text_key": "362177114", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "H2: A1-A4: SELECT PATIENT INFORMATION WAS UNAVAILABLE FROM THE SITE. 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": "356198824", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "H3, H6) THE SYSTEM WAS SERVICED IN THE FIELD. IN SUMMARY, THE SYSTEM PERFORMED AS INTENDED AND NO FAULTS WERE FOUND. CODES B01, C19, AND D14 ARE APPLICABLE. 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": "356198825", "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 WHILE PLACING SCREWS IN L3, EXTENDING UP FROM AN EXISTING FUSION, THEY HAD A PRETTY SIGNIFICANT MEDIAL BREACH IN ONE OF THE L3 SCREWS (LEFT). THE RIGHT SCREW LOOKED TO BE SLIGHTLY OFF BUT WAS STILL IN THE PEDICLE AS EXPECTED, WHEREAS THE LEFT SCREW WAS NOT EVEN IN PEDICLE. THERE WAS TROUBLESHOOTING PRESENT. IT WAS REPORTED THAT THEY REGISTERED LEVELS L3, L4, L5, AND PLANNED TO PUT NEW TRAJECTORIES IN L3 AND REMOVED HARDWARE AT L4 TO SEND TRAJECTORIES AND PLACE NEW SCREWS AT L4. THEY REGISTERED, STARTED AT L3 (SURGEON PERFORMED ACCURACY CHECK, CHICKEN FOOT ON SPINOUS PROCESS AND RUN IT DOWN TO ENSURE ACCURACY. WHEN THE SURGEON DID THAT, THE CHICKEN FOOT LOOKED TO BE FLOATING ABOUT 5 MILLIMETERS (MM) ABOVE THE SPINOUS PROCESS. AN ACCURACY TEST WAS PERFORMED BY PUTTING IN THE DIVOT AND IT DID NOT ALIGN. THEY SENT TO NEW SNAPSHOT, THE IMAGE LOOKED GOOD ON SCREEN - SENT TO L3 TRAJECTORY ON THE RIGHT AND EVERYTHING LOOKED GOOD. SO THROUGHOUT THE CASE, THE ROBOT WAS NOT INDICATING ANYTHING WAS OFF, BUT WHEN THEY GOT TO PLACING RODS IS WHEN THEY DISCOVERED L3 SCREW WAS OFF TRAJECTORY. SCREWS WERE ONLY PLACED AT L3 AND RIGHT L4. THERE WAS NO IMPACT TO PATIENT'S OUTCOME AND SURGICAL DELAY WAS REPORTED AS LESS THAN ONE-HOUR." } ], "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": "12/06/2024;01/07/2025;02/12/2025" } ] }