{ "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": "3009185973-2017-00723", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20171004", "manufacturer_address_2": "", "pma_pmn_number": "PK101791", "date_of_event": "20170911", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "HEALTH PROFESSIONAL", "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": "GM", "manufacturer_contact_area_code": "", "date_added": "20171004", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "692854", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20171004", "brand_name": "ROSA SURGICAL DEVICE", "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 2.5.8", "catalog_number": "N/A", "lot_number": "N/A", "other_id_number": "N/A", "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": [ "Unintended Collision", "Device Displays Incorrect Message", "Unintended Collision", "Device Displays Incorrect Message" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "11/02/2017", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250814", "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": "20171004", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Consequences Or Impact To Patient", "No Code Available", "No Consequences Or Impact To Patient", "No Code Available" ] } ], "distributor_city": "", "date_report": "20171107", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "6913615", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20170911", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Inspection" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "250773724", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE DEVICE (B)(4) DATA LOG FILES FROM THE SUBJECT SURGERY HAS BEEN INSPECTED FOR INVESTIGATION PURPOSE. INVESTIGATION CONFIRMED THAT THE DEVICE (B)(4) WORKED AS INTENDED, THERE WAS NO DEVICE MALFUNCTION. DEPENDING ON THE ORIENTATION AND POSITIONING OF THE TRAJECTORIES PLANNED BY THE USER, THE ROBOT MAY HAVE TO MAKE A MOVEMENT THROUGH PATIENT'S HEAD TO REACH THE TRAJECTORY. THIS IS A NORMAL DEVICE BEHAVIOR. IN THIS CASE, THE USER HAS TO MODIFY THE TRAJECTORY IN ORDER TO ENABLE THE ROBOT ARM TO REACH THE TRAJECTORY WITHOUT PASSING THROUGH PATIENT'S HEAD. IN THIS SPECIFIC CASE THAT IS WHAT THE USER DID IN ORDER TO REACH THE REQUIRED TRAJECTORY, AFTER THE TRAJECTORY WAS MODIFIED THE ROBOT ARM REACHED THE DESIRED TRAJECTORY. NOTE: THE ROSA SURGICAL DEVICES ARE EQUIPPED WITH A VIGILANCE DEVICE FOR MONITORING THE ROBOT ARM MOVEMENTS. THIS OPERATING PRINCIPLE APPLIES TO ALL STEPS OF THE DEVICE USE. AS SOON AS THE USER RELEASES THE VIGILANCE DEVICE, THE ROBOT ARM MOVEMENT IS INTERRUPTED. (B)(4)." }, { "mdr_text_key": "88150616", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE DEVICE HAS NOT BEEN EVALUATED YET FOR INVESTIGATION PURPOSE. ONCE THE EVALUATION WILL BE PERFORMED, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED." }, { "mdr_text_key": "88150617", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A SURGERY AN ERROR MESSAGE POP UP AND THE ROBOT REFUSED TO MOVE. THE SURGEON HAD LATER TO STOP THE AUTOMATIC MOVEMENT BECAUSE THE ROBOT ARM WOULD HAVE TOUCHED PATIENT HEAD. THE SURGEON MODIFIED THE TRAJECTORY AND NO MORE ISSUES WERE NOTICED." } ], "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": "11/07/2017" } ] }