{ "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": "3005075696-2026-00020", "type_of_report": [ "Initial submission", "Followup", "Followup", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20260102", "manufacturer_address_2": "", "pma_pmn_number": "K230064", "date_of_event": "20251210", "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": [ "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "3079830", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20260102", "manufacturer_contact_f_name": "JUSTIN", "device_date_of_manufacturer": "20221130", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "9647", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20260102", "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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OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: ASM0206, SERIAL/LOT: UNKNOWN. H3, H6) THE SYSTEM WAS SERVICED IN THE FIELD AND THE SURGICAL ARM WAS REPLACED. CODES B01, C13, AND D02 ARE APPLICABLE. H3, H6) CLINICAL DATA WAS RECEIVED AND IS PENDING ANALYSIS. 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": "389867912", "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 TWO SCREWS WERE PLACED AND THE SURGEON NOTED THAT THEY WERE POSITIONED MORE MEDIALLY THAN INTENDED. THIS RAISED CONCERNS ABOUT ALLEGED INACCURACY OF THE GUIDANCE SYSTEM. THE SURGEON PERFORMED A SECOND MEDTRONIC IMAGING SPIN AND TRANSFERRED THE NEW IMAGES TO THE GUIDANCE SYSTEM. BEFORE PLACING A THIRD SCREW, THE SURGEON DECIDED TO ABORT USE OF THE GUIDANCE SYSTEM. ALL SCREWS WERE REMOVED FROM THE PATIENT AND THE GUIDANCE SYSTEM WAS REPLACED WITH A NAVIGATION SYSTEM FOR RE-PLACEMENT OF THE SCREWS. IT WAS NOTED THAT THERE WERE TWO UNUSED STANDARD SPINS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT AND SURGICAL DELAY WAS LESS THAN ONE-HOUR. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE TRAJECTORIES WERE NOTED TO DEVIATE BETWEEN 3.5 AND 10 MILLIMETERS (MM) ON ALL THREE OF THE ORIGINALLY PLACED SCREWS, BASED ON MEASUREMENTS FROM THE SECOND COMPLETED MEDTRONIC IMAGING SPIN, MEASURING FROM THE SCREW THAT WAS STILL PLACED AS WELL AS NOTED PATH SEEN ON IMAGING FROM WHERE SCREWS HAD BEEN REMOVED." }, { "mdr_text_key": "395962079", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "H3, H6: THE SURGICAL ARM, SERIAL NUMBER: (B)(6), WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. NO PROBLEM WAS FOUND. THE REPORTED EVENT COULD NOT BE DUPLICATED BY MEDTRONIC PERSONNEL. CODES B01, C19, AND D14 ARE APPLICABLE TO THIS ANALYSIS. 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": "392704255", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE INACCURACY COULD NOT BE REPRODUCED WITH THE OLD SURGICAL ARM." }, { "mdr_text_key": "392704256", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "B5 ADDITIONAL INFORMATION. SURGICAL ARM PRODUCT ID: ASM0206 SERIAL NUMBER UPDATED TO (B)(6). H3, H6: THE SURGICAL ARM WAS RETURNED FOR PRODUCT ANALYSIS. THE ANALYSIS IS PENDING COMPLETION. CODES B21, C21, AND D16 ARE APPLICABLE. H3, H6: THE EXPORTS WERE RETURNED FOR CLINICAL ANALYSIS. THE ANALYSIS DETERMINED THAT THE PROBABLE CAUSE OF THE REPORTED DEVIATION WAS DUE TO A PATIENT SHIFT. 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": "01/28/2026;02/18/2026;07/02/2026;07/27/2026;07/30/2026" } ] }