{ "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": "3009185973-2020-00032", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20200205", "manufacturer_address_2": "", "pma_pmn_number": "K182417", "date_of_event": "20200110", "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": "20200205", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "134650", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20200205", "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": [ "Use of Device Problem", "Use of Device Problem" ], "reporter_state_code": "MA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "03/13/2020", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250824", "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": "20200205", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Code Available", "No Code Available" ] } ], "distributor_city": "", "date_report": "20200326", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "9670509", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20200110", "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": "317560607", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "A DEVICE HISTORY RECORD REVIEW AND COMPLAINT HISTORY REVIEW DID NOT IDENTIFY CONTRIBUTING FACTORS. THE RECENT SOFTWARE UPDATE OF THE DEVICE FROM ROSA BRAIN TO ROSA ONE - BRAIN APPLICATION, INCLUDES TECHNICAL UPDATES WHICH ARE PART OF THE PRODUCT VERSION. ONE OF THEM IS THE CHANGE OF THE ROBOT JOINTS POSITIONS AND THE CORRECT USAGE TO NAVIGATE FLUENTLY IN REFERENCE POSITIONS. THIS CHANGE IS CONSIDERED AS A NORMAL BEHAVIOR AND DO NOT IMPACT THE ROBOT FUNCTIONALITY. THE USERS MIGHT NOT BE FAMILIAR WITH THE NEW MANAGEMENT OF THE ROBOT ARM MOVEMENT. INDEED, THERE IS NO EVIDENCE THAT THE OPERATING SURGEONS WERE TRAINED TO THE CHANGES EXISTING BETWEEN THE ROSA BRAIN AND THE ROSA ONE DEVICES." }, { "mdr_text_key": "317560608", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "SURGEON PERFORMING MARKER REGISTRATION, NOTED THAT MOVEMENT IS MARKEDLY DIFFERENT POST-UPGRADE. SURGEONS BOTH NOTED THE INCREASED DIFFICULTY WITH MOVEMENT USING POINTER TO PERFORM REGISTRATION. SURGEON FINDS IT \"ALMOST UNUSABLE\". SURGEONS EXPRESSED CONCERN FOR FUTURE SCHEDULED CASES; ADDITIONALLY NOTED THAT MAYBE WILL NOT PURCHASE SECOND SYSTEM IF CONTINUES TO BE DIFFICULT TO USE. DELAY OF 30 MINUTES. PATIENT UNDER ANESTHESIA, PINNED, BUT AWAKE; DBS PROCEDURE." }, { "mdr_text_key": "177804586", "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. (B)(4)." }, { "mdr_text_key": "177804587", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "SURGEON PERFORMING MARKER REGISTRATION, NOTED THAT MOVEMENT IS MARKEDLY DIFFERENT POST-UPGRADE. SURGEONS BOTH NOTED THE INCREASED DIFFICULTY WITH MOVEMENT USING POINTER TO PERFORM REGISTRATION. SURGEON FINDS IT \"ALMOST UNUSABLE\". SURGEONS EXPRESSED CONCERN FOR FUTURE SCHEDULED CASES; ADDITIONALLY NOTED THAT MAYBE WILL NOT PURCHASE SECOND SYSTEM IF CONTINUES TO BE DIFFICULT TO USE. DELAY OF 30 MINUTES. PATIENT UNDER ANESTHESIA, PINNED, BUT AWAKE; DBS PROCEDURE." } ], "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": "03/26/2020" } ] }