{ "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": "3009185973-2017-00670", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20170726", "manufacturer_address_2": "", "pma_pmn_number": "PK101791", "date_of_event": "20170710", "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": [ "HEALTH PROFESSIONAL" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "GM", "manufacturer_contact_area_code": "", "date_added": "20170726", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "525918", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20170726", "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": "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", "Loss of Data", "Unintended Collision", "Loss of Data" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "11/08/2017;11/08/2017", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250826", "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": "20170726", "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": "20171214", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "6743203", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20170710", "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": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "187140156", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE DELAY OCCURRED DURING THE SURGERY WAS 30 MINS. (B)(4)," }, { "mdr_text_key": "81002591", "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": "81002592", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A SURGERY THE ROBOTIC ARM COLLIDED WITH THE DEVICE COVERS, GENERATING A COMMUNICATION ERROR IN THE SYSTEM AND A SHUTDOWN. WHEN THE DEVICE WAS RESTARTED THE REGISTRATION OF THE PATIENT POSITION WAS NOT ACCURATE ANYMORE. THIS EVENT OCCURRED RIGHT BEFORE IMPLANTING THE LAST ELECTRODE, FOR THAT REASON THE SURGEON DECIDED NOT TO IMPLANT IT." }, { "mdr_text_key": "130545187", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE DEVICE (B)(4) HAS NOT BEEN INSPECTED FOR INVESTIGATION PURPOSE. ANALYSIS OF DATA LOG FILES FORM THE SUBJECT EVENT FOR INVESTIGATION PURPOSE DETERMINED THAT THE PATIENT HEAD WAS TOO CLOSE TO THE ROBOT DURING THE SURGERY. THE IFU WAS REVIEWED FOR INVESTIGATION PURPOSE, THIS REVIEW INDICATED THAT THE MOST PROBABLE ROOT CAUSE IS INSUFFICIENT INFORMATION IN THE IFU REGARDING THE RECOMMENDED DISTANCE BETWEEN PATIENT¿S HEAD AND THE ROBOT. CORRECTED DATA: DATE RECEIVED BY MANUFACTURER. VISUAL AND FUNCTIONAL INSPECTION." } ], "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": "11/11/2017;12/14/2017" } ] }