{ "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": "1723170-2019-04702", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20190830", "manufacturer_address_2": "", "pma_pmn_number": "K180307", "date_of_event": "20190731", "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": "20190830", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "745118", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20190830", "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": "TPL0059-05", "catalog_number": "TPL0059-05", "lot_number": "", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20190801", "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": [ "Use of Device Problem", "Use of Device Problem" ], "reporter_state_code": "MA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "09/10/2019", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250813", "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": "20190830", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Tissue Damage", "Complaint, Ill-Defined", "Tissue Damage", "Complaint, Ill-Defined" ] } ], "distributor_city": "", "date_report": "20190920", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "8950727", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20190731", "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": "156287853", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED." }, { "mdr_text_key": "156287854", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT ALL OF THE SCREWS WERE NOT TO PLAN. ALL OF THE LEFT SIDE SCREWS WERE IN THE SPINAL CANAL AND THE RIGHT HAND SCREWS WERE LATERAL TO PLAN. PRIOR TO THE PROCEDURE, A 10 POINT ACCURACY CHECK WAS DONE AND THE GUIDANCE SYSTEM WAS ACCURATE ON ALL TRAJECTORIES. A SURGICAL ARM AND SHOULDER CHECK WERE ALSO DONE AND BOTH PASSED. THE TRAJECTORIES WERE PLANNED BY THE SURGEON AND THE C-ARM WAS CALIBRATED. THE GUIDANCE SYSTEM WAS PLACED ON THE BED AND DRAPED AS NORMAL. DURING THE PROCEDURE, EXPOSURE AND MARKING FILMS WERE DONE BEFORE THE SURGICAL SYSTEM WAS ATTACHED TO THE PATIENT. EXPOSE WAS GENEROUS AND THERE WERE NO ISSUE WITH SOFT TISSUE PRESSURE. A DUAL CLAMP WAS USED AT T4 AND T5. THE CONSTRUCT WAS RIGID BEFORE THE GUIDANCE SYSTEM WAS PLACED TO ATTACH TO THE CLAMP. A 3DEFINE SCAN AND DRAW SPINE WERE THEN COMPLETED. REGISTRATION WAS COMPLETED WITH TWO AP AND TWO OBLIQUE SHOTS. DURING IMAGING, RESPIRATION WAS SUSPENDED TO AVOID AN CROSS VIEW ERRORS. SEGMENTATION WAS ACHIEVED ON FIRST ATTEMPT AT LABELING AND ALL TRAJECTORIES WERE GREEN. REGISTRATION WAS APPROVED BY THE SURGEONS. THE LEFT T3 TRAJECTORY WAS PERFORMED FIRST USING LONG TOOLS, BUT WAS THEN ADJUSTED TO USE SHORT TOOLS. THE SCREW PLAN WAS ADJUSTED TO BRING THE SCREW TULIP OUT LATERAL. THE SURGEON BURRED DOWN THE ENTRY POINT TO AVOID ANY POSSIBILITY OF SKIVE. THE SURGICAL ARM WAS RESENT AND THE TRAJECTORY WAS INSTRUMENTED WITH NO DEVIATIONS. LEFT T4 WAS DONE NEXT. THE SURGICAL ARM WAS SENT AND THE SCREW WAS RE-PLANNED FIVE TIMES. EACH TIME THE PLAN WAS ADJUSTED TO BE MORE LATERAL AND INCREASING THE ANGLE TO CLEAR THE DUAL CLAMP. INITIALLY LONG TOOLS WERE USED, BUT THE ADJUSTMENTS ALLOWED FOR SHORT TOOLS TO BE USED. THE ENTRY POINT WAS BURRED DOWN TO AVOID THE POSSIBILITY OF SKIVE. ON THE FIFTH ATTEMPT, THE TRAJECTORY WAS SATISFACTORY AND THE TRAJECTORY WAS INSTRUMENTED WITH NO DEVIATIONS. T5 WAS NOT PLANNED AS THERE WAS TRAUMA TO THE LEVEL AND WAS NOT TO BE OPERATED ON. LEFT T6 WAS THE NEXT TRAJECTORY. THIS TRAJECTORY WAS RE-PLANNED THREE TIMES TO ADJUST THE ENTRY POINT. THE ENTRY POINT WAS BURRED DOWN TO AVOID THE POSSIBILITY OF SKIVE. AFTER FINAL ADJUSTMENTS, THE SURGICAL ARM WAS SENT AND THE TRAJECTORY WAS INSTRUMENTED WITH NO DEVIATIONS. LEFT T7 WAS THE NEXT TRAJECTORY TO BE INSTRUMENTED. THE SURGEON NOTED THAT THE TRAJECTORY LOOKED TOO MEDIAL SO THE PLAN WAS ADJUSTED TO SWING THE SCREW OUT LATERALLY TO MATCH THE PREVIOUS TRAJECTORIES. THE ENTRY POINT WAS BURRED DOWN TO AVOID THE POSSIBILITY OF SKIVE. THE SURGEON NOTED THE TRAJECTORY STILL LOOKED OFF AND THE ARM WAS RESENT TO LEFT T4. AT T4, INSTRUMENTS WERE SENT DOWN THE ARM GUIDE TO SEE IF ANY SHIFT HAD OCCURRED. INSTRUMENTS FOLLOWED THE SAME TRAJECTORY SO THE SURGICAL ARM WAS RESENT TO LEFT T7. LEFT T7 WAS THEN INSTRUMENTED WITH NO DEVIATIONS. THE SURGICAL ARM WAS THEN SENT TO RIGHT T7. LONG TOOLS HAD TO BE USED AND INSTEAD OF INSTRUMENTING THE SURGEON DECIDED TO CONTINUE TO THE RIGHT T6 TRAJECTORY IN ORDER TO STAY WITH SHORT TOOLS UNTIL THE END. THE RIGHT T6 ENTRY POINT WAS BURRED DOWN AND THE INSTRUMENTED WITH A LATERAL DEVIATION. THE DEVIATION WAS NOTED BY THE SURGEON WITH THE GUIDE WIRE DID NOT ANCHOR IN THE BONE. THE C-ARM WAS BROUGHT IN TO CONFIRM AND A BALL FEELER WAS USED TO CONFIRM THE LATERAL TRAJECTORY INTO THE JOINT SPACE. THE SURGEON NOTED THAT THEY FELT SOMETHING WITH THE SYSTEM WAS OFF SO THE SURGICAL ARM WAS SENT AGAIN TO LEFT T4. INSTRUMENTS WERE SENT DOWN THE ARM GUIDE AT T4 AND AGAIN THERE WAS NO SHIFT. THE PLAN FOR RIGHT T6 WAS ADJUSTED TWICE FOR THE TULIP HEAD TO SWING LATERALLY AND THE TRAJECTORY DEPTH WAS EDITED TO ACCOMMODATE SHORT TOOLS. RIGHT T6 WAS INSTRUMENTED WITH NO DEVIATION AND THE PLACEMENT OF THE GUIDEWIRE WAS CONFIRMED TO BE ANCHORED IN THE BONE BY THE SURGEON. RIGHT T4 WAS NEXT. THE ENTRY POINT WAS BURRED DOWN TO AVOID THE POSSIBILITY OF SKIVE. THE TRAJECTORY WAS INSTRUMENTED WITH NO DEVIATION. RIGHT T2 AS NEXT AND THE PLAN WAS ADJUSTED TO ACCOMMODATE SHORT TOOLS. THE TRAJECTORY WAS INSTRUMENTED WITH NO DEVIATIONS. RIGHT T7 WAS THEN INSTRUMENTED USING LONG TOOLS WITH NO DEVIATIONS. AFTER INSTRUMENTATION, THE C-ARM WAS BROUGHT IN TO CONFIRM GUIDE WIRE PLACEMENT. IMAGES WERE CONFIRMED BY THE SURGEONS AND SCREW PLACEMENT WAS PERFORMED. EACH TRAJECTORY WAS TAPPED WITH A 4.5 MM TAP AND A SCREW WAS PLACED WITH A HAND DRIVER. THE GUIDE WIRES WERE REMOVED WHEN THE SCREW WAS AT THE CORRECT DEPTH. THE C-ARM WAS BROUGHT IN A GAIN TO CONFIRM PLACEMENT OF THE SCREWS IN BOTH AP AND OBLIQUE POSITIONS. THE SCREWS WERE CONFIRMED ACCURATE BY THE SURGEONS. THE SURGICAL SYSTEM WAS UNMOUNTED AND REMOVED FROM THE BED. THE LEFT SIDE SCREWS THAT WERE PLACED IN THE SPINAL CANAL WERE FENESTRATED AND CEMENT WAS USED SO CEMENT WAS INJECTED INTO THE SPINAL CANAL. THE PATIENT DID NOT EXPERIENCE ANY SYMPTOMS RELATED TO THE DEVIATED SCREWS OR BONE CEMENT BEING INJECTED INTO THE SPINAL CANAL. NO ACTIONS OR INTERVENTIONS WERE TAKEN. THE CAUSE OF THE DEVIATIONS WAS NOT DETERMINED. THE SURGERY WAS NOT DELAYED MORE THAN AN HOUR AND THE CASE WAS COMPLETED." }, { "mdr_text_key": "191204360", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ANALYSIS OF THE SOFTWARE EXPORTS FOUND THE COMPLAINT WAS CONFIRMED. THE EXPORT DATA FILE AND LOG WERE EXAMINED. PLANNING WAS REVIEWED AND HIGHER THAN 12° AXIAL DEGREES IN PLANNING WAS OBSERVED ON ALL LEFT SIDE TRAJECTORIES. REGISTRATION WAS VERIFIED TO BE ACCURATE. CONFIRMATION IMAGES WERE PROVIDED, SHOWING THE K-WIRES TO BE ACCURATE EXPECT T6 RIGHT, WHICH WAS CONFIRMED LATERAL. CONSIDERING THE OPEN APPROACH, POSSIBLE SOFT TISSUE PRESSURE AND HIGH ANGLES IN PLANNING, THE ROOT CAUSE OF THE DEVIATIONS IS SOFT TISSUE PRESSURE ON THE TOOLS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED." }, { "mdr_text_key": "191204361", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE REPORTED THAT NO ERROR MESSAGES WERE DISPLAYED AND THE POSITION OF THE PATIENT WAS NOT ALTERED DURING THE PROCEDURE. THE REPRESENTATIVE DID NOT KNOW OF ANY SIGNIFICANT FORCES USED DURING THE PROCEDURE, BUT THERE WAS A POSSIBILITY OF A PATIENT SHIFT EVEN THOUGH NONE WAS OBSERVED BY THE SURGEON OR THE REPRESENTATIVE. THE K-WIRES WERE CONFIRMED TO BE ACCURATE WITH THE C-ARM DURING THE PROCEDURE. AFTER VERIFICATION, THE TRAJECTORIES WERE TAPPED AND SCREWS WERE PLACED." } ], "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": "09/20/2019" } ] }