{ "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": "7000 CENTRAL AVENUE NE RCW215", "manufacturer_g1_city": "CAESAREA HEFA,IL", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "61227132", "event_type": "Injury", "report_number": "3005075696-2024-00015", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20240207", "manufacturer_address_2": "", "pma_pmn_number": "K203005", "date_of_event": "20240124", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "55432", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "6122713209", "noe_summarized": "1", "manufacturer_contact_l_name": "BELMER", "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": "612", "date_added": "20240207", "manufacturer_contact_f_name": "GLEN", "device_date_of_manufacturer": "20180501", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1791955", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20240207", "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": "20240130", "device_report_product_code": "OLO", "device_age_text": "DA", "device_evaluated_by_manufacturer": "Y", "combination_product_flag": "N", "udi_di": "07290109181158", "udi_public": "07290109181158", "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", "Incorrect, Inadequate or Imprecise Result or Readings", "Use of Device Problem" ], "reporter_state_code": "FL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "03/18/2024", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20250819", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "30", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "6122", "patient": [ { "patient_sequence_number": "1", "date_received": "20240207", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "61 YR", "patient_sex": "Male", "patient_weight": "112 KG", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Pain", "Pain" ] } ], "distributor_city": "", "date_report": "20240415", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "IS", "manufacturer_contact_city": "MINNEAPOLIS", "mdr_report_key": "18660055", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20240129", "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": "334772235", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "H3, H6: A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO PERFORM A SYSTEM CHECK OUT AND THEY FOUND THAT THE SYSTEM FUNCTIONED AS INTENDED. NO PROBLEMS WERE DETECTED. B01, C19, D14 ARE APPLICABLE TO THE SYSTEM CHECKOUT. THE EXPORTS/LOGS HAVE BEEN RETURNED FOR CLINICAL ANALYSIS. THE ANALYSIS IS STILL IN PROGRESS. B21, C21, D16 ARE APPLICABLE TO THE CLINICAL ANALYSIS. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED." }, { "mdr_text_key": "334772236", "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 A SURGEON DECIDED TO BRING A PATIENT BACK TO REVISE TWO SCREWS. THE SCOPE WAS TO IMPLANT EIGHT SCREWS FROM L2 TO L5. THE SITE INITIALLY ATTEMPTED TO REGISTER USING CT TO FLUORO, BUT THAT REGISTRATION FAILED SIX TIMES DUE TO THREE TITANIUM CAGES BEING IN THE FIELD OF VIEW AND THE PATIENT BEING VERY LARGE. THE SURGEON EXPECTED TO FAIL THAT REGISTRATION DUE TO THE CAGES IN THE VIEW AND THE PATIENT BEING VERY LARGE. THE SURGEON HAD BEEN SUCCESSFUL IN ACQUIRING A PASSING REGISTRATION IN THIS CIRCUMSTANCE BEFORE WHICH IS WHY THEY KEPT TRYING TO GET A REGISTRATION. AFTER THE SURGEON FELT LIKE THEY HAD GIVEN CT TO FLUORO REGISTRATION A CHANCE, THE SITE RESORTED TO USING SCAN AND PLAN INSTEAD. SCAN AND PLAN REGISTRATION WAS SUCCESSFUL. THE SURGEON INSERTED THE EIGHT SCREWS AND COMPLETED THE CASE. THE SURGEON VERIFIED THE SCREW PLACEMENT AFTER THE CASE USING FLUORO. HOWEVER, THE SURGEON ORDERED A CT OF THE PATIENT AFTER THE CASE, WHICH MADE THEM REALIZE TWO OF THE EIGHT SCREWS WERE TOO SUPERIOR. THE TRAJECTORY WAS DEVIATED 3.5 MM TO 10MM. THE SURGEON THEN DECIDED TO SCHEDULE A REVISION CASE TO RE-INSERT THE TWO SUPERIOR SCREWS. THE SURGEON SAID THE L4 AND L5 SCREWS ON THE RIGHT WERE TOO SUPERIOR. THE MANUFACTURER REPRESENTATIVE SUSPECTED THAT TOO MUCH PRESSURE WAS APPLIED BY THE SURGEON WHEN SCREW IN THE SCREWS. DUE TO SUSPECTED INCREASED BONE DENSITY AT L4 AND L5, THE SURGEON HAD TO APPLY MORE PRESSURE FOR THE SCREW TO TAKE. THE PATIENT EXPERIENCED LOW BACK PAIN DUE TO THE DEVIATION AND THE PROCEDURE WAS DELAYED BY 25 MINUTES." }, { "mdr_text_key": "341029712", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "H3, H6: THE EXPORTS WERE REVIEWED FOR CLINICAL ANALYSIS. IT WAS DETERMINED THAT THE PROBABLE CAUSE OF THE REPORTED SUPERIOR DEVIATION AT L4 AND L5 RIGHT WAS TOOL SKIVING DURING INSTRUMENTATION. SUPERIOR SKIVING WAS OBSERVED IN SUB-OPTIMAL PLANNING, WHILE THE REPORTED EXCESSIVE PRESSURE MAY HAVE PUSHED THE SCREWS SUPERIORLY DURING SCREW INSERTION. 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": "55432", "manufacturer_contact_exchange": "612", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "04/15/2024" } ] }