{ "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": "3005075696-2026-00065", "type_of_report": [ "Initial submission", "Followup", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20260227", "manufacturer_address_2": "", "pma_pmn_number": "K203005", "date_of_event": "20260204", "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": "GM", "manufacturer_contact_area_code": "", "date_added": "20260227", "manufacturer_contact_f_name": "JUSTIN", "device_date_of_manufacturer": "20200304", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "538422", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20260227", "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 THE SCREWS WERE REMOVED AFTER THE FAULTY POSITION WAS SEEN INTRA-OPERATIVELY AND WERE NOT SEEN ON POST-OPERATIVE THREE-DIMENSIONAL (3D) SCANS. THE AMOUNT OF DEVIATION WAS ESTIMATED TO BE 10-15MM." }, { "mdr_text_key": "398447612", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "H2, B5: EVENT DETAILS HAVE BEEN UPDATED. 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": "394284035", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "CONTINUATION OF D10: SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: ASM0206, SERIAL: UNK A1-A4: PATIENT INFORMATION WAS NOT AVAILABLE. H3, H6: THE EXPORTS/LOGS WERE RETURNED FOR CLINICAL ANALYSIS. THE ANALYSIS IS STILL IN PROGRESS. MULTIPLE DEVICE CODES AND PATIENT CODES WERE APPLIED. BELOW CLARIFIES WHAT EACH IS ASSOCIATED WITH. A0908 - INACCURACY A150204 - ARM NOT REACHING THE SNAP SHOT POSITION E012202 - PARALYSIS E2114 - PENETRATED SPINAL CORD 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": "394284036", "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 PERFORMING A PERCUTANEOUS VOYAGER SPINE CASE WITH CT TO FLUORO AND CONTROLLING THE SCREW PLACEMENTS WITH X-RAY, THE SURGEON NOTICED THAT THE SCREWS WERE PLACED WRONG. ONE OF THE HOLES DRILLED WAS LOCATED TOO MEDIAL AND THE SPINAL CORD WAS PENETRATED LEADING TO PARALYSIS OF THE PATIENT. IT WAS ALSO NOTED THAT THE NURSE INTENDED TO PERFORM A SNAPSHOT, BUT THE ARM COULD NOT REACH THE SNAP SHOT POSITION, BECAUSE THE PERCUTANEOUS EXTENDERS OF THE VOYAGER SYSTEM LOGGED IN THE SYSTEM PREVENTED THE ARM FROM REACHING SNAPSHOT POSITION. THE MANUFACTURER REPRESENTATIVE ADVISED THE SITE TO DELETE THE VOYAGER EXTENDERS FROM THE SOFTWARE, SO THAT THE ROBOT COULD LOWER ITSELF INTO THE SNAPSHOT POSITION. THE SITE WAS THEN ABLE TO PERFORM A SNAPSHOT AND THEN PERFORMED THE NAVIGATION ACCURACY TESTING AND THEREAFTER THE ANATOMY ACCURACY TESTING. NAVIGATION WAS ACCURATE, BUT THE REPRESENTATIVE SUSPECTED THE ANATOMY WAS NOT. THE REPRESENTATIVE ADVISED THEM TO REDO THE CT TO FLUORO REGISTRATION. THE PROCEDURE WAS DELAYED LESS THAN 1 HOUR." }, { "mdr_text_key": "398546786", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "CONCOMITANT PRODUCT ASM0206 SERIAL #: (B)(6). 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": "03/25/2026;03/31/2026;05/06/2026" } ] }