{ "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": "3005075696-2024-00163", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20241126", "manufacturer_address_2": "", "pma_pmn_number": "K230064", "date_of_event": "20241030", "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": "20241126", "manufacturer_contact_f_name": "JUSTIN", "device_date_of_manufacturer": "20220707", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2573019", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20241126", "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": "20241104", "device_report_product_code": "OLO", "device_age_text": "DA", "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", "Incorrect, Inadequate or Imprecise Result or Readings" ], "reporter_state_code": "PA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "12/16/2024", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20250825", "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": "20241126", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "80 YR", "patient_sex": "Male", "patient_weight": "82 KG", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Unspecified Tissue Injury", "Unspecified Tissue Injury" ] } ], "distributor_city": "", "date_report": "20250109", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "IS", "manufacturer_contact_city": "MOUNDS VIEW", "mdr_report_key": "20784964", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20241030", "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": "357653659", "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 WHEN INSERTING SCREWS FOR L2-L5 AND NOTING THAT LEFT L3 AND L4 WERE OFF BY A FEW MILLIMETERS LATERALLY. THE SURGEON REMOVED THE SCREWS AND REINSERTED THE SCREWS MANUALLY. THE SURGEON THEN BEGAN INSERTING SCREWS ON THE RIGHT. RIGHT L2 WAS OFF MEDIALLY AND THERE WAS A DURA TEAR. THE SURGEON DISCONTINUED USE OF THE SYSTEM AND PERFORMED THE ENTIRE RIGHT SIDE WITHOUT USE OF NAVIGATION. CC NOTED THAT A BILATERAL RETRACKER WAS PLACED ON THE PATIENT DURING REGISTRATION. IT WAS REPORTED THAT THE AMOUNT OF TRAJECTORY DEVIATION WAS UNKNOWN, BUT WAS BELIEVED TO BE LESS THAN 3.5 MILLIMETERS (MM). THERE WAS NO DELAY." }, { "mdr_text_key": "357653660", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "H3, H6: THE EXPORTS/LOGS WERE RETURNED FOR CLINICAL ANALYSIS. THE ANALYSIS IS STILL IN PROGRESS. 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": "362085947", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "H3, H6: THE EXPORTS/LOGS WERE RETURNED FOR CLINICAL ANALYSIS. THE ANALYSIS CONCLUDED THE PROBABLE ROOT CAUSE OF THE REPORTED DEVIATION IS A PATIENT SHIFT. IT IS POSSIBLE THAT THE SURGEON (WHICH WAS OPERATING ON THE LEFT SIDE) LEANED SLIGHTLY ON THE PATIENT, CAUSING A SLIGHT LATERAL DEVIATION, WHICH MAY HAVE AFFECTED THE OTHER TRAJECTORIES AS WELL, BUT SINCE THE SHIFT WAS MINIMAL, IT LIKELY WAS NOT A CONCERN FOR THE OTHER PLACEMENTS. HOWEVER, WITHOUT INTRA/POST-OP IMAGES, IT IS HARD TO CONFIRM. SINCE THE LEFT SIDE WAS INSTRUMENTED FIRST, AND A LATERAL SHIFT WAS OBSERVED, THIS COULD HAVE INFLUENCED THE RIGHT SIDE. FOR THE RIGHT SIDE, ONLY L2 ON THE RIGHT WAS INSTRUMENTED, AND THEN THE GUIDANCE SYSTEM WAS ABORTED. IT IS POSSIBLE THAT A SLIGHT MEDIAL DEVIATION OCCURRED ON THE RIGHT AS WELL, HAVING LEFT BEING LATERAL, WITH A POTENTIAL FOR SOFT TISSUE PRESSURE FOR L2 RIGHT SINCE L2 IS CLOSE TO THE INCISION LINES. ADDITIONALLY, LATERAL SKIVING POTENTIAL COULD HAVE CONTRIBUTED TO THE REPORTED DEVIATIONS FOR L3 LEFT AND L4 LEFT AS BONE WORK WAS PREFORMED, HOWEVER, THIS CLAIM WAS NOT CONFIRMED. IT IS HELPFUL TO PERFORM ANATOMY CHECKS THROUGHOUT THE CASE TO ENSURE ACCURACY AND IDENTIFY ANY POTENTIAL SHIFTS IN ANATOMY. 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": "01/09/2025" } ] }