{ "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": "3009185973-2020-00071", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20200304", "manufacturer_address_2": "", "pma_pmn_number": "K182417", "date_of_event": "20200204", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "OTHER HEALTH CARE PROFESSIONAL", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "HEALTH PROFESSIONAL" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20200304", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "248716", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20200304", "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": "3.1.1.1295", "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": [ "Imprecision", "Imprecision" ], "reporter_state_code": "FL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/29/2020", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250811", "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": "20200304", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Code Available", "No Code Available" ] } ], "distributor_city": "", "date_report": "20200730", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "9785190", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20200212", "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": "192684057", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "UDI# : (B)(4). THE DEVICE HAS NOT BEEN EVALUATED YET FOR INVESTIGATION PURPOSE. ONCE THE EVALUATION IS PERFORMED, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED." }, { "mdr_text_key": "192684058", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "A COMPLAINT WAS PRESENTED TO A FIELD SERVICE ENGINEER (FSE) ON 12 FEB 2020 BY A RESIDENT. THE MESSAGE SAID \"WE RECENTLY HAD TWO ROSA BIOPSIES THAT WERE NON-DIAGNOSTIC. BASED ON POSTOP IMAGING, IT LOOKS LIKE THE TRAJECTORIES WERE TOO SHORT ¿ THE NEEDLE TRAJECTORY DIDN¿T GO DEEP ENOUGH\". AFTER RECEIVING THIS MESSAGE THE FSE REACHED OUT TO ANOTHER FSE TO PERFORM A FULL PREVENTATIVE MAINTENANCE (PM) ON THE (B)(4) ROBOT. THE PM WAS COMPLETED ON 13 FEB 2020. ROBOT (B)(4) PASSED ALL PM TESTING. AFTER PERFORMING A PM, THE FSE HAD A BIOPSY CASE. AN OARM SPIN WAS PERFORMED WITH THE BIOPSY NEEDLE IN THE HEAD ON THIS PATIENT AND THE TRAJECTORY ON EXTREMELY ACCURATE AND THE SURGEON WAS VERY SATISFIED. ON THIS DAY WE ALSO FOUND ON ONE OF THE TWO PATIENTS HE HAD PREVIOUSLY MENTIONED WAS DIAGNOSED DESPITE HIS INITIAL THOUGHTS AND COMMENTS. THEREFORE, ONLY ONE PATIENT WAS LESS THAN A CM SHALLOW." }, { "mdr_text_key": "319581174", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "DHR REVIEW AND REVIEW OF COMPLAINT HISTORY DID NOT IDENTIFY ANY CONTRIBUTORY FACTORS TO THE EVENT. A FULL ANALYSIS OF THE DATA LOGS AND OF THE PATIENT FOLDER HAS BEEN PERFORMED AND CONCLUDED THAT THE POST-OPERATIVE IMAGES SUGGEST THAT THERE IS AN INACCURACY IN DEPTH AT THE TARGET POINT OF ABOUT 11MM BUT THE DEPTH IS DEPENDENT ON SEVERAL PARAMETERS THAT ARE NOT MANAGED BY THE ROBOT AND IT IS THEREFORE IMPOSSIBLE TO CONCLUDE ON ITS ORIGIN. THE ENTRY POINT COULD NOT BE FOUND BECAUSE OF THE REDUCED NUMBER OF SLICES OF THE POST-OPERATIVE MRI AND THE REDUCED QUALITY OF IMAGERY. HOWEVER, IT WAS ALSO NOTICED THAT THE REGISTRATION VERIFICATION WAS NOT PERFORMED CORRECTLY. NO FAILURE OF THE DEVICE WAS FOUND DURING THE REVIEW OF AVAILABLE DATA.ANALYSIS SHOWED THAT THERE WAS AN INACCURACY AS REPORTED." }, { "mdr_text_key": "319581175", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "A COMPLAINT WAS PRESENTED TO A FIELD SERVICE ENGINEER (FSE) ON 12 FEB 2020 BY A RESIDENT. THE MESSAGE SAID \"WE RECENTLY HAD TWO ROSA BIOPSIES THAT WERE NON-DIAGNOSTIC. BASED ON POSTOP IMAGING, IT LOOKS LIKE THE TRAJECTORIES WERE TOO SHORT ¿ THE NEEDLE TRAJECTORY DIDN¿T GO DEEP ENOUGH\". AFTER RECEIVING THIS MESSAGE THE FSE REACHED OUT TO ANOTHER FSE TO PERFORM A FULL PREVENTATIVE MAINTENANCE (PM) ON THE BS18989 ROBOT. THE PM WAS COMPLETED ON 13 FEB 2020. ROBOT BS18989 PASSED ALL PM TESTING. AFTER PERFORMING A PM, THE FSE HAD A BIOPSY CASE. AN OARM SPIN WAS PERFORMED WITH THE BIOPSY NEEDLE IN THE HEAD ON THIS PATIENT AND THE TRAJECTORY ON EXTREMELY ACCURATE AND THE SURGEON WAS VERY SATISFIED. ON THIS DAY WE ALSO FOUND ON ONE OF THE TWO PATIENTS HE HAD PREVIOUSLY MENTIONED WAS DIAGNOSED DESPITE HIS INITIAL THOUGHTS AND COMMENTS. THEREFORE, ONLY ONE PATIENT WAS LESS THAN A CM SHALLOW." } ], "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": "07/30/2020" } ] }