{ "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": "3005075696-2026-00090", "type_of_report": [ "Initial submission", "Followup", "Followup", "Followup", "Followup" ], "product_problem_flag": "N", "date_received": "20260423", "manufacturer_address_2": "", "pma_pmn_number": "K230064", "date_of_event": "20260325", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "55112", "reporter_occupation_code": "003", "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": "JA", "manufacturer_contact_area_code": "", "date_added": "20260423", "manufacturer_contact_f_name": "JUSTIN", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1028224", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20260423", "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": "", "date_returned_to_manufacturer": "20260414", "device_report_product_code": "OLO", "device_age_text": "DAY", "device_evaluated_by_manufacturer": "Y", "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": [ "Incorrect, Inadequate or Imprecise Result or Readings", "Use of Device Problem" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "04/27/2026;05/13/2026;06/05/2026;06/30/2026", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20260903", "health_professional": "N", "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": "20260423", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Muscle Weakness/Atrophy", "Nerve Damage", "Paralysis", "Insufficient Information" ] } ], "distributor_city": "", "date_report": "20260630", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "IS", "manufacturer_contact_city": "MOUNDS VIEW", "mdr_report_key": "24970438", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20260326", "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": "399364375", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "H3, H6: CLINICAL ANALYSIS RESULTS PENDING. CODES B21, C21, AND D16 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": "399364376", "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 DRILLING ON THE RIGHT SIDE OF L2, BACKING OCCURRED. AFTERWARDS, THE PHYSICIAN DECIDED TO CONTINUE. THEY LEFT THE SITE AT THAT TIME. IN THE EVENING ON MARCH 25, THE MANUFACTURING REPRESENTATIVE (REP) REPORTED THAT THERE WAS A POSSIBILITY THAT THE ROOT WAS TOUCHED DURING DRILLING RATHER THAN BACKING AT SFDC. IN THE MORNING OF MARCH 26, THE PHYSICIAN FROM SPINE VISITED AND SAID THAT THE PATIENT HAD LOWER LIMB SYMPTOMS AND THAT THEY WOULD CONDUCT A DETAILED EXAMINATION. THERE WAS LESS THAN AN HOUR DELAY. IMPACT ON PATIENT OUTCOME WAS UNKNOWN. ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE REPORTED THAT THE NERVE WAS DAMAGED. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT AFTER THE EVENT, NORMAL OPERATION OF THE GUIDANCE SYSTEM WAS CONFIRMED." }, { "mdr_text_key": "15577692693", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT FIXATION WAS PERFORMED AT T10¿L2 FOR A BURST FRACTURE AT T12. INITIALLY, THE ENTIRE CONTOUR OF THE L2 VERTEBRAL BODY WAS NOT INCLUDED, AND L2 WAS NOT LABELED DURING REGISTRATION; HOWEVER, RE-IMAGING WAS PERFORMED AND THE ISSUE WAS RESOLVED. PEDICLE SCREW (PS) INSERTION WAS PROGRESSING SMOOTHLY; HOWEVER, WHEN THE SCREW HAD BEEN INSERTED APPROXIMATELY HALFWAY, PATIENT BACKING OCCURRED (PATIENT MOVEMENT). ALTHOUGH BODY MOVEMENT WAS CLEARLY OBSERVED, THE GUIDANCE SYSTEM PROCEDURE CONTINUED BASED ON THE PHYSICIAN¿S JUDGMENT. AFTER PS INSERTION, CONFIRMATION WAS PERFORMED USING IMAGING. THE SCREW PLAN ON THAT DAY MAY HAVE BEEN SLIGHTLY MEDIAL. AFTER IMAGING WITH THE IMAGING SYSTEM, THE IMAGES WERE TRANSFERRED TO MZ; HOWEVER, SEGMENTATION OF L2 COULD NOT BE PERFORMED, AND RE-IMAGING WAS CONDUCTED. WITH REPEATED IMAGING, REGISTRATION WAS COMPLETED. DURING DRILLING AT L2, PATIENT MOVEMENT OCCURRED. AFTER CONFIRMATION UNDER FLUOROSCOPY, THE GUIDANCE SYSTEM USE WAS RESUMED FROM L1. DECREASED MUSCLE STRENGTH IN THE RIGHT LOWER LIMB WAS OBSERVED POST-OP. PARALYSIS WORSENED, AND EMERGENCY DECOMPRESSION WAS PERFORMED ON FRIDAY. THE DRILL TRAJECTORY HAD PASSED THROUGH THE INTERVERTEBRAL FORAMEN, AND THE NERVE ROOT HAD BEEN SEVERED. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT L2 RIGHT TRAJECTORY WAS DEVIATED. THE DEVIATION WAS CAUDAL DIRECTION. THE WORKFLOW OF THE PROCEDURE WAS THE LATERAL POSITION, THE PIN WAS PLACED ON THE L2 AND L4 OF SPINOUS PROCESS AND THE MIST BRIDGE WAS MOUNTED. AP AND OBLIQUE IMAGE WERE TAKEN, THEY WERE MERGED WITHOUT PROBLEM. THE PROCEDURE WAS TH10-L2 FUSION. THE SURGEON STARTED FROM TH10L. THE SCREW INSERTION ORDER WAS TH10L, TH11L, L1L, L2L, L1R, TH12R, TH11R, TH10R. THE ACCURACY CHECK WAS DONE BEFORE L2R. NO ISSUE WAS FOUND. THE PATIENT MOVED DURING THE DRILLING AT L2R THEN THE SURGEON SKIPPED L2R. THE REP THOUGHT THAT THE NERVE WAS DAMAGED AT THAT TIME. THE PATIENT MIGHT MOVE DUE TO CONTACT WITH THE NERVE. THE SCREW OF L2R WAS INSERTED WITHOUT THE GUIDANCE SYSTEM. OTHER SCREWS WERE PLACED WITH USING THE GUIDANCE SYSTEM." }, { "mdr_text_key": "16077692694", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "B5 AND H6 ADDITIONAL INFORMATION. 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": "399610207", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "G3 PMA / 510(K) # CORRECTION 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": "16150934448", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "H3, H6: THE LOGS AND EXPORTS WERE RETURNED FOR CLINICAL ANALYSIS. THE ANALYSIS DETERMINED THAT IT WAS LIKELY THAT THE SKIVING POTENTIAL IDENTIFIED IN THE PLAN WAS THE PRIMARY FACTOR CONTRIBUTING TO THE REPORTED DEVIATION. HOWEVER, SINCE THE INTRAOPERATIVE SCANS WERE NOT PROVIDED, THIS CONCLUSION CANNOT BE CONFIRMED WITH FULL CERTAINTY. CODES B01, C13, AND D11 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." } ], "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": "04/27/2026;06/03/2026;06/08/2026;06/30/2026" } ] }