{ "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": "1723170-2019-02279", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20190511", "manufacturer_address_2": "", "pma_pmn_number": "K163221", "date_of_event": "20190410", "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": "20190511", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "395687", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20190511", "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": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20190627", "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": [ "Electrical /Electronic Property Problem", "Malposition of Device", "Electrical /Electronic Property Problem", "Malposition of Device" ], "reporter_state_code": "NC", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "08/20/2019", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250804", "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": "20190511", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "50 YR", "patient_sex": "", "patient_weight": "91", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Pain", "Tissue Damage", "Pain", "Tissue Damage" ] } ], "distributor_city": "", "date_report": "20190822", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "8602351", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20190412", "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": "190596279", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ANALYSIS OF THE CLINICAL EXPORT FILES FOUND THE SUSPECTED CAUSE OF THE REPORTED DEVIATIONS WAS SUB-OPTIMAL PLANNING OF THE RIGHT L4 SCREW, RESULTING IN A POSSIBLE LATERAL-SUPERIOR SKIVING OF THE TOOLS. AN ACCURATE TRAJECTORY WAS DRILLED AFTER THE DEVIATED ONE. THE K-WIRES PLACED USING THE GUIDANCE SYSTEM WERE FOUND TO BE DEVIATED, SLIGHTLY SUPERIOR, BUT STILL INSIDE OF THE PEDICLE. A LATERAL DEVIATION COULD NOT BE CONFIRMED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED." }, { "mdr_text_key": "144796610", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED." }, { "mdr_text_key": "144796611", "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 3DEFINE FAILED DURING THE PROCEDURE. A SECOND 3DEFINE WAS SUCCESSFUL. REGISTRATION WAS PERFORMED QUICKLY. UPON INSTRUMENTING FIRST TRAJECTORY (LEFT L4), THE WORKSTATION BEEPED AND GAVE AN INSTRUCTION TO LOCK THE ARM IN THE SOFTWARE. THE SURGEON DID NOT HAVE TOOLS IN THE ARM GUIDE WHEN THIS NOTIFICATION OCCURRED. THE ARM WAS RELOCKED IN THE SOFTWARE AND ANOTHER 3DEFINE WAS PERFORMED. THE 3DEFINE FAILED AGAIN ON THE FIRST ATTEMPT. THE SECOND ATTEMPT FOR 3DEFINE WAS SUCCESSFUL. REGISTRATION WAS PERFORMED QUICKLY, AND SURGEON INSTRUMENTED ALL 4 TRAJECTORIES. AP AND LATERAL X-RAY IMAGES VERIFIED WIRES WERE ACCURATELY PLACED. TWO DAYS FOLLOWING THE CASE, THE REP RECEIVED NOTIFICATION THAT THE RIGHT L4 SCREW HAD BEEN MISPLACED LATERAL AND SUPERIOR. REVISION PROCEDURE WAS SCHEDULED FOR SATURDAY (B)(6) 2019 TO REMOVE SCREW AND PLACE NEW ONE. IT WAS ALSO NOTED THAT THE WORKSTATION WOULD NOT ALLOW IMPORT OR EXPORT OF ANY DATA. THE PATIENT COMPLAINED OF RIGHT LEG PAIN POST OPERATIVELY. ADDITIONAL INFORMATION RECEIVED FROM THE REP INDICATED THAT THE SCREW INACCURACY WAS GREATER THAN 3.5MM BUT LESS THAN 10MM. THE PATIENT'S SYMPTOMS HAD RESOLVED AFTER THE SUCCESSFUL REVISION SURGERY ON (B)(6) 2019. 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": "08/22/2019" } ] }