{ "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": "3009185973-2020-00040", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20200207", "manufacturer_address_2": "", "pma_pmn_number": "K182417", "date_of_event": "20200107", "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": [ "COMPANY REPRESENTATIVE", "HEALTH" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20200207", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "143305", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20200207", "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": "", "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", "Unintended Collision" ], "reporter_state_code": "NE", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250808", "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": "20200207", "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": "20200207", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "9680439", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20200108", "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": "178122710", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "UDI#: (B)(4). DURING THE SURGERY, A COLLISION WAS DETECTED BY THE SOFTWARE AND OCCURRED BETWEEN THE TOOL AND THE ANCHOR BOLT. THIS EVENT COULD HAVE BEEN AVOIDED BY RELEASING THE FOOT PEDAL, AS EXPLAINED IN THE USER MANUAL. THEN, AN UNRECOVERABLE FAILURE OCCURRED, PROVOKING THE DEVICE SHUTDOWN, DUE TO THE SHUTDOWN OF THE SOFTWARE WHICH WAS PROBABLY PROVOKED BY THE PREVIOUS TOOL COLLISION. HOWEVER, NOT ENOUGH EVIDENCES ARE PROVIDED TO CONFIRM IT AND THEN, TO DETERMINE THE ROOT CAUSE FOR THIS ISSUE. THE SECOND UNRECOVERABLE ERROR, NOT MENTIONED IN THE COMPLAINT DESCRIPTION, OCCURRED WHEN THE ROBOT ARM WAS ABOUT TO BE SENT IN PREDEFINED PARKING POSITION. LOG ANALYSIS SHOWS THAT THE SOFTWARE RECEIVED THE INFORMATION THAT THE MOVE WAS SUCCESSFULLY FINISHED WHEN HE DID NOT EVEN HAVE TIME TO START." }, { "mdr_text_key": "178122711", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "DURING GUIDANCE OF THIRD TRAJECTORY, THE ROBOT ARM COLLIDED WITH AN ANCHOR BOLT, AND THE RESULTING IMPACT KNOCKED IT OUT OF THE PATIENT¿S HEAD. THE CASE WAS THEN ABORTED. BECAUSE A FIELD SERVICE ENGINEER (FSE) WAS NOT PRESENT AT THE TIME OF THE EVENT, WE ARE STILL MISSING A LOT OF THE DETAILS. A FSE PERFORMED ACCURACY CHECKS ON FRIDAY, 10-JAN-2020, AND VERIFIED THAT THE SYSTEM PASSED THOSE CHECKS SUCCESSFULLY." } ], "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": "" } ] }