{ "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": "N", "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": "3009185973-2021-00084", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20210325", "manufacturer_address_2": "", "pma_pmn_number": "K200511", "date_of_event": "20210303", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "003", "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": "20210325", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "468610", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "U", "date_received": "20210325", "brand_name": "ROSA ONE", "generic_name": "COMPUTER-ASSISTED SURGICAL DEVICE", "manufacturer_d_name": "MEDTECH SA", "manufacturer_d_address_1": "ZAC EUREKA", "manufacturer_d_address_2": "900 RUE DU MAS DE VERCHANT", "manufacturer_d_city": "MONTPELLIER, LANGUEDOC-ROUSSILLON", "manufacturer_d_state": "", "manufacturer_d_zip_code": "34000", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "FR", "manufacturer_d_postal_code": "34000", "device_operator": "HEALTH PROFESSIONAL", "model_number": "ROSA ONE", "catalog_number": "ROSAS00203", "lot_number": "3.1.4.1650", "other_id_number": "", "device_availability": "Yes", "device_report_product_code": "HAW", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Neurological Stereotaxic Instrument", "medical_specialty_description": "Neurology", "regulation_number": "882.4560", "device_class": "2" } } ], "product_problems": [ "Computer Software Problem", "Computer Software Problem" ], "reporter_state_code": "FL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/22/2021", "mfr_report_type": "", "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": "20210325", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Clinical Signs, Symptoms or Conditions", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20210722", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "11567249", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20210303", "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": "325814427", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "WE HAD A DIFFICULT TIME REGISTERING TODAY. WE USED THE MEDTRONIC BONE FIDUCIALS WITH AN OMNITOM CT SCANNER. THE FIDUCIALS WERE DIFFICULT TO DEFINE ON THE CT SCAN SO WE ENDED UP USING 4 FIDUCIALS AND WERE STILL UNABLE TO GET UNDER 1MM OF ACCURACY. THE SURGEON WANTED TO MOVE FORWARD WITH A 1.25MM RNS. THE VERIFICATION LOOKED GOOD THOUGH. WE ALSO HAD A RANDOM SHUTDOWN WHILE SITTING ON TRAJECTORY AND WERE FORCED TO DO A FULL SHUTDOWN AND REDRIVE TO THE TRAJECTORY. THE REGISTRATION DIFFICULTY CAUSED ABOUT A 30MIN DELAY IN SURGERY. THE FULL SHUTDOWN WAS ABOUT 8 MINUTES TO REDRIVE TO THE TRAJECTORY." }, { "mdr_text_key": "325814428", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "A FULL ANALYSIS OF THE DATA LOGS HAS BEEN PERFORMED AND THIS ANALYSIS OF THE THREE REGISTRATIONS SHOWED THAT THE INCORRECT ERRORS COMPUTED ARE DUE TO AN INACCURATE ALIGNEMENT BETWEEN THE MARKERS PLANNED AND THE MARKERS ACTUALLY RECORDED WITH THE ARM. REMOVING ONE MARKER PERMITTED TO REDUCE THE ERROR BUT ALIGNING THE PLANNING OF MARKERS WITH ROBOT MARKER ACQUISITIONS WOULD HAVE PROVIDE BETTER RESULTS. THEN, A VIRTUAL MEMORY ERROR WAS DETECTED. IT PROVOKED THE UNEXPECTED COMMUNICATION ERROR AND THE RESTART OF THE APPLICATION. THIS ISSUE WILL BE ADDRESSED THROUGH THE CONTINUOUS IMPROVEMENT PROCESS OF OUR PRODUCTS." }, { "mdr_text_key": "242165800", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE DEVICE HAS NOT BEEN EVALUATED YET FOR INVESTIGATION PURPOSE. ONCE THE EVALUATION IS PERFORMED, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED. UNIQUE IDENTIFIER (UDI) #: (B)(4)." }, { "mdr_text_key": "242165801", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "WE HAD A DIFFICULT TIME REGISTERING TODAY. WE USED THE MEDTRONIC BONE FIDUCIALS WITH AN OMNITOM CT SCANNER. THE FIDUCIALS WERE DIFFICULT TO DEFINE ON THE CT SCAN SO WE ENDED UP USING 4 FIDUCIALS AND WERE STILL UNABLE TO GET UNDER 1MM OF ACCURACY. THE SURGEON WANTED TO MOVE FORWARD WITH A 1.25MM RNS. THE VERIFICATION LOOKED GOOD THOUGH. WE ALSO HAD A RANDOM SHUTDOWN WHILE SITTING ON TRAJECTORY AND WERE FORCED TO DO A FULL SHUTDOWN AND REDRIVE TO THE TRAJECTORY. THE REGISTRATION DIFFICULTY CAUSED ABOUT A 30MIN DELAY IN SURGERY. THE FULL SHUTDOWN WAS ABOUT 8 MINUTES TO REDRIVE TO THE TRAJECTORY." } ], "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": "07/22/2021" } ] }