{ "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": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "1723170-2019-03974", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20190708", "manufacturer_address_2": "", "pma_pmn_number": "K163221", "date_of_event": "20190610", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "COMPANY REPRESENTATIVE", "HEALTH" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20190708", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "563813", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20190708", "brand_name": "MAZOR X SYSTEM", "generic_name": "ORTHOPEDIC STEREOTAXIC INSTRUMENT", "manufacturer_d_name": "MEDTRONIC NAVIGATION, INC", "manufacturer_d_address_1": "826 COAL CREEK CIRCLE", "manufacturer_d_address_2": "", "manufacturer_d_city": "LOUISVILLE", "manufacturer_d_state": "CO", "manufacturer_d_zip_code": "80027", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "80027", "device_operator": "HEALTH PROFESSIONAL", "model_number": "TPL0059", "catalog_number": "TPL0059", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "OLO", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "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": [ "Imprecision", "Imprecision" ], "reporter_state_code": "NC", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "10/15/2019", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250814", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20190708", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Tissue Damage", "Tissue Damage" ] } ], "distributor_city": "", "date_report": "20191019", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "8768669", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20190610", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "191042362", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "EVALUATION OF THE RETURNED SOFTWARE EXPORT FILES INDICATED THAT THE PROBABLE CAUSE OF THE DEVIATION EXPERIENCED IN THE OR IS COMPROMISED ACCURACY OF THE SURGICAL ARM, AFTER THE SURGICAL ARM HAS FAILED THE ADVANCED ACCURACY TEST PRIOR TO THE SURGERY. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED." }, { "mdr_text_key": "150303243", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: KIT0574, SERIAL/LOT #: (B)(4), UBD: 28-OCT-2021, UDI#: (B)(4) - SOFTWARE EXPORTS WERE RETURNED, HOWEVER EVALUATION WAS NOT COMPLETE AT THE TIME OF THIS REPORT. A FOLLOW UP REPORT WILL BE SENT ONCE EVALUATION IS COMPLETE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED." }, { "mdr_text_key": "150303244", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "MEDTRONIC RECEIVED INFORMATION FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING A GUIDANCE DEVICE BEING USED IN A SPINAL PROCEDURE. IT WAS REPORTED THAT THE SURGEON PERFORMED AN L3-5 LATERAL MAZOR X CASE. PREPLANNING WAS DONE WITH THE SURGEON PRIOR TO THE PROCEDURE. SPECIAL ATTENTION WAS PAID TO AXIAL ANGLES AND SKIVE POTENTIALS. L3-5 OLIF WAS PERFORMED PRIOR TO USING THE MAZOR X. THE PATIENT WAS POSITIONED FOR A LATERAL PROCEDURE. THE SCHANZ PIN WAS PLACED IN LEFT PSIS. AND THE SCHANZ ARM WAS ATTACHED. 3DEFINE AND DRAW SPINE WERE SUCCESSFUL. REGISTRATION WAS SUCCESSFUL USING AUTO REGISTRATION AND THE BASIC ALGORITHM. ALL 6 WIRES WERE PLACED STARTING WITH RIGHT L3. ALL RIGHT SIDE TRAJECTORIES WERE INSTRUMENTED PRIOR TO LEFT SIDE TRAJECTORIES. LATERAL CONFIRMATION FLOURO IMAGES WERE TAKEN FOR EACH TRAJECTORY AND APPEARED ACCURATE. A FINAL AP CONFIRMATION SHOWED RIGHT L3 WAS LATERAL. RIGHT L3 WAS ADJUSTED IN THE PLAN AND DRILLED AGAIN. FINAL AP AND LATERAL FLOURO IMAGES WERE TAKEN AND ALL 6 SCREWS APPEARED TO BE PLACED ACCURATELY. THE POST-OP CT SHOWED LEFT SIDE SCREWS MISPLACED MEDIALLY AND RIGHT SIDE SCREWS MISPLACED LATERALLY. UPON CASE COMPLETION, IT WAS DISCOVERED THAT THE 3D MARKER WAS CROSS THREADING THROUGH THE TARGET EXTENDER. THIS TARGET EXTENDER WAS JUST REPLACED A MONTH AGO. THE 3D MARKER WAS INDEED TIGHT AND SECURE ON THE TARGET EXTENDER, BUT THE SCREW WOULD CONTINUE TO TWIST AND NOT FULLY SEAT. A REVISION PROCEDURE WAS PLANNED FOR (B)(6) 2019 TO REPLACE SCREWS. POST-OP AXIAL CT PHOTOS WERE TAKEN ON THE DAY OF THE REPORT, AFTER UPLOADING TO THE MAZOR X SOFTWARE. THERE WERE NO ADDITIONAL COMPLICATIONS REPORTED OR ANTICIPATED AS A RESULT OF THE EVENT." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "10/19/2019" } ] }