{ "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": "1723170-2019-04202", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20190724", "manufacturer_address_2": "", "pma_pmn_number": "K163221", "date_of_event": "20190624", "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": "20190724", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "616078", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20190724", "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": "", "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", "Mechanical Problem", "Imprecision", "Mechanical Problem" ], "reporter_state_code": "NC", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250724", "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": "20190724", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Known Impact Or Consequence To Patient", "No Known Impact Or Consequence To Patient" ] } ], "distributor_city": "", "date_report": "20190724", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "8822165", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20190624", "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": "152059851", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "OTHER RELEVANT DEVICE(S) ARE: MAS2351 SCHANZ ARM (X2). DEVICE EVALUATED BY MFR: EVALUATION OF THE RETURNED SOFTWARE EXPORT FILES REVEALED AN UNSECURE PLATFORM FIXATION. THE SCHANZ PIN WAS INSERTED TO S1 VERTEBRAE INSTEAD OF BEING INSERTED TO THE PSIS. MOREOVER, THE INSERTION DEPTH OF THE SCHANZ PIN DOES NOT PROVIDE AN ADEQUATE PLATFORM STABILIZATION, AS IT WAS NOT FULLY DRILLED INTO THE BONY ANATOMY. THE INVESTIGATION TEAM CONCLUDED THE ROOT CAUSE FOR THE REPORTED DEVIATION IS AN INADEQUATE PLATFORM FIXATION. THE SCHANZ PIN HAD BEEN INSERTED INTO S1 INSTEAD OF INTO THE PSIS AND WAS NOT FULLY DRILLED. CONSEQUENTLY, THE PLATFORM'S STABILITY WAS COMPROMISED. IT IS BELIEVED THAT DUE TO THE PLATFORM INSTABILITY, A SLIGHT EXTERNAL FORCE, APPLIED ON THE PLATFORM, MIGHT HAVE LED TO THE REPORTED LATERAL DEVIATIONS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED." }, { "mdr_text_key": "152059852", "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 STEALTH EDITION CAMERA UPGRADE WAS PERFORMED THIS PAST FRIDAY. THE 4.2 SOFTWARE HAD BEEN INSTALLED FOR A FEW MONTHS. STEALTH EDITION WAS NOT USED FOR THIS CASE. THE PATIENT WAS PLACED IN THE LATERAL POSITION FOR LATERAL PROCEDURE WITH THE LEFT SIDE UP. A SCHANZ PIN WAS PLACED IN LEFT PSIS AND 3DEFINE ATTEMPT WAS SUCCESSFUL. THE ARM WAS THEN SENT TO DRAPE FOR DRAW SPINE, BUT AN ERROR MESSAGE INDICATED THAT DRAPE POSITION WAS UNREACHABLE. THE 3D WORKING VOLUME WAS THOUGHT TO HAVE BEEN THE REASON FOR THIS. THE ARM WAS REMOUNTED WITH THE ELBOW JOINT ANGLE ADJUSTED SLIGHTLY. THE SECOND 3DEFINE WAS SUCCESSFUL AND THE ARM WAS SUCCESSFULLY SENT TO DRAPE MODE. DRAW SPINE WAS SUCCESSFUL. 3D MARKER SENT TO AP. THE 3D MARKER WAS ADJUSTED ANTERIOR TO BETTER CAPTURE THE AP. ERROR 295 APPEARED WHEN ATTEMPTING TO SEND THE ARM TO TAKE OBL IMAGE: ¿OBL POSITION IS UNREACHABLE. CONSIDER RE-DRAWING SPINE USING A DIFFERENT VERTEBRAL BODY.¿ THE ARM WAS MANIPULATED POSTERIOR AND THEN SUCCESSFULLY SENT TO THE OBL IMAGE. REGISTRATION WAS QUICKLY ACHIEVED. UPON SENDING TO LEFT L4, THE ARM WAS CLOSE TO COLLIDING WITH THE PATIENT. EMERGENCY STOP WAS PUSHED AND A NEW SOLUTION WITH A LONGER DISTANCE WAS SELECTED. THE ARM WAS RESENT TO LEFT L4 AND THE TRAJECTORY APPEARED FAR LATERAL TO THE PLAN. THE ARM WAS THEN SENT TO RIGHT L4 WHICH APPEARED TO MATCH THE PLAN. RIGHT L4 AND L5 WERE DRILLED. ARM WAS RESENT TO LEFT L4 AND THE TRAJECTORY AGAIN APPEARED FAR LATERAL. SURGEON THEN MADE THE DECISION TO ONLY INSTRUMENT UNILATERAL SCREWS. UPON INSERTION OF THE RIGHT L4 SCREW, THE SCREW APPEARED TO BE PLACED LATERAL AND SURGEON MADE THE INTRA-OPERATIVE DECISION TO NOT USE SCREWS FOR THE PROCEDURE. AP FLUORO SHOT CONFIRMED RIGHT L4 WAS MISPLACED LATERAL. AFTER THE CASE WAS ABORTED, IT WAS NOTICED THAT THE 3D WORKING VOLUME DISAPPEARED ON THE OPERATION SCREEN. SHOW WAS SELECTED ON THE BOTTOM MENU AND WORKING VOLUME WAS UNSELECTED AND SELECTED. THE 3D WORKING VOLUME WAS STILL NOT VISIBLE. A WHITE LINE WHICH APPEARED TO BE A GLITCH WAS VISIBLE. A SOFT RESTART WAS THEN PERFORMED, AND THE SOFTWARE RESTARTED ON THE MOUNTING SCREEN, KICKING THE REP OUT OF OPERATION. ALSO, AFTER TAKING THE SYSTEM OFF THE BED AND ATTEMPTING TO SEND THE ARM TO STORAGE POSITION, ERROR 8025 OCCURRED: ¿PREDEFINED POSITION IS UNREACHABLE. EXAMINE FOR COLLISION WITH SHOULDER OR POSITIONER OR EXAMINE WORK VOLUME.¿ A HARD RESTART WAS PERFORMED TO FIX THE PROBLEM. FOLLOWING THE CASE, THE SOFTWARE ALSO FROZE ON THE SETTINGS SCREEN, PROMPTING A SOFT RESTART. IT WAS ALSO NOTED THAT THE SCHANZ ARM WAS FAULTY AND WOULD NOT LOCK. AS A RESULT THEY FELT IT MOVED DURING THE PROCEDURE AND MADE THE ROBOT INACCURATE WITH THE SCREW PLACEMENT. THE PATIENT WAS BROUGHT BACK 2 DAYS LATER TO RE-DIRECT THE SCREWS. THERE WAS NO PATIENT HARM OR 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": "" } ] }