{ "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": "2026-07-07", "results": { "skip": 0, "limit": 1, "total": 203186 } }, "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": "3010266064-2020-01547", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20200427", "manufacturer_address_2": "", "pma_pmn_number": "K191223", "date_of_event": "20190822", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "OTHER", "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": "20200427", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "463807", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20200427", "brand_name": "NAVIO SURGICAL SYSTEM US", "generic_name": "ORTHOPEDIC STEREOTAXIC INSTRUMENT", "manufacturer_d_name": "BLUE BELT TECHNOLOGIES", "manufacturer_d_address_1": "2905 NORTHWEST BLVD STE 40", "manufacturer_d_address_2": "", "manufacturer_d_city": "PLYMOUTH", "manufacturer_d_state": "MN", "manufacturer_d_zip_code": "55441", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "55441", "device_operator": "HEALTH PROFESSIONAL", "model_number": "NPFS02000", "catalog_number": "NPFS02000", "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": "00885556628416", "udi_public": "00885556628416", "openfda": { "device_name": "Orthopedic Stereotaxic Instrument", "medical_specialty_description": "Neurology", "regulation_number": "882.4560", "device_class": "2" } } ], "product_problems": [ "Computer Software Problem", "Computer Software Problem" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "08/27/2020", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250725", "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": "20200427", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "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": "20200828", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10000604", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20190822", "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": "319308855", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE DEVICE WAS USED IN THE TREATMENT AND CASE SCREENSHOTS WERE RETURNED. DHR REVIEW FOUND THAT THE SOFTWARE VERSION HAS BEEN VALIDATED. A COMPLAINT HISTORY REVIEW FOUND SIMILAR REPORTS, THIS ISSUE WILL CONTINUE TO BE MONITORED. THIS IS AN IDENTIFIED FAILURE MODE WITHIN THE RISK FILE. THE SURGICAL TECHNIQUE (500197) PROVIDES INSTRUCTIONS FOR SYSTEM USAGE. SCREENSHOT REVIEW FOUND THAT NAVIO PERFORMED WITHIN EXPECTED PARAMETERS. IT WAS REPORTED THAT THE INITIAL IMPLANT WAS TOO BIG. THE INITIAL IMPLANT PLACEMENT AND SIZING MET THE REQUIREMENTS FOR THE SYSTEM. THE SYSTEM DOES NOT ADJUST TO MEDIAL/LATERAL SIZING, WHICH THE USER MAY HAVE EXPECTED. THE SCREENSHOTS ALSO SHOWED THAT THE BONE WAS NOT WELL PAINTED LATERALLY. IT IS RECOMMENDED TO PAINT ON THE EPICONDYLES IF THE USER IS PLANNING TO USE IT AS A REFERENCE. THE SCREENSHOTS SHOW THAT THE IMPLANT POSITION WAS RESET. WHEN THE POSITION WAS RESET, THE IMPLANT WAS NOT RESIZED. THEREFORE, THE IMPLANT APPEARED AS IT WOULD NOTCH SINCE THE SIZE WAS NOT ADJUSTED. THE NAVIO 7 SOFTWARE INITIALLY PLACES THE IMPLANT WITH THE SMALLEST IMPLANT SIZE. THE SOFTWARE THEN INCREASES THE SIZE OF THE IMPLANT, ONE AT A TIME, UNTIL IT FINDS THE SMALLEST FEMUR SIZE THAT DOES NOT NOTCH ANTERIORLY, BASED ON THE NOTCHING REGION DEFINED BY NAVIO. THE REFERENCE FOR NOTCHING IS LOCATED 20MM PROXIMAL TO THE MOST SUPERIOR ASPECT OF THE IMPLANT DESIGN. THIS REGION CAN BE DEFINED ON EITHER THE HIGH-CONFIDENCE MESH DEFINED BY THE SURGEON, OR THE SYSTEM GENERATED MODEL. IT IS RECOMMENDED TO PAINT THE DEFINED ANTERIOR CORTEX REGION, AS NOTED BY THE LIGHT GREY OUTLINE ON THE BONE MODEL IN THE FREE COLLECTION. THE SURGEON CAN ADJUST THE SIZE AND POSITION OF THE IMPLANT COMPONENTS BASED ON THEIR DISCRETION AND PREFERENCES. NO CONTAINMENT OR CORRECTIVE ACTIONS ARE RECOMMENDED AT THIS TIME. WITHOUT SUPPORTING DOCUMENTS, A THOROUGH CLINICAL/MEDICAL INVESTIGATION CANNOT BE PERFORMED. IF ADDITIONAL SUPPORTING DOCUMENTS ARE RECEIVED THIS COMPLAINT WILL BE REASSESSED." }, { "mdr_text_key": "189086076", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING CASE USING NAVIO 7.0 MISCALCULATION OF THE ROBOT FOR ROTATION WAS EXPERIENCED AND DURING PLANNING SCREEN THE FEMUR STARTED OFF NOTCHING AND POSTERIOR CUTS WERE VERY BIG CONSIDERING PROPER FEMUR SIZING AND TIBIA MODEL WAS NOT CENTERED. BECAUSE OF THE ISSUES WITH PLAN MISCALCULATION FROM THE BEGINNING, DOCTOR WENT TO A MANUAL PROCEDURE. NO INJURIES INVOLVED" } ], "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": "08/28/2020" } ] }