{ "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": "3009185973-2018-00261", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20181004", "manufacturer_address_2": "", "pma_pmn_number": "PK101791", "date_of_event": "20180920", "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": "GM", "manufacturer_contact_area_code": "", "date_added": "20181004", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "777525", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20181004", "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": "ROSA", "lot_number": "2.5.8.4", "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": [ "Computer Software Problem", "Computer Software Problem" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "02/07/2019", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250727", "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": "20181004", "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": "20190307", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "7934196", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20180920", "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": "122665816", "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": "122665817", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THE SURGEON SENT TO THE FIELD SERVICE ENGINEER 2 PICTURES OF THE SCREEN OF THE ROBOT SHOWING THE ERROR VALUES OF THE INITIAL POINTS AND THE ERROR MESSAGE: \"THE REGISTRATION COULD NOT BE COMPUTED. DO YOU WANT TO PERFORM AGAIN THE REGISTRATION OR RETRY BY MODIFYING THE INITIAL POINTS? \". THE INITALS POINTS WERE ALL RATED GREEN (CORRECT) ON THE RECOLLECTION OF INITIAL POINTS. THE SURGEON ASKED WHY EVERYTHING IS GREEN WHEREAS THE REGISTRATION IS NOT POSSIBLE. THE FSE ADVISED TO RETRY FIRST SETTING THE INITIAL POINTS AGAIN AND HAVE THE ERROR BELOW 2MM FOR EACH POINT. LATER, THE SURGEON INFORMED THE FSE THAT THE REGISTRATION WAS SUCCESSFUL." }, { "mdr_text_key": "312044140", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT THE REGISTRATION COULD NOT BE COMPUTED AND THE DEVICE DISPLAYED A MESSAGE TO RE-DO THE REGISTRATION OR MODIFY THE INITIAL POINTS. A DHR REVIEW AND A COMPLAINT HISTORY REVIEW WERE PERFORMED AND DID NOT IDENTIFY ANY CONTRIBUTORY FACTORS TO THE EVENT. ANALYSIS OF DATA LOGS DETERMINED THAT THE REGISTRATION WORKFLOW WAS NOT EXECUTED PROPERLY. INDEED, THE SURGEON MODIFIED REFERENCE POINTS MARKED ON IMAGES WITHOUT ALSO CORRECTING THE CORRESPONDING ROBOT POINTS WITH THE LASER. THIS PRACTICE, NOT CORRECT, WAS PERFORMED EACH TIME THE USER WANTED TO ADJUST POINTS TOGETHER. FOR THE LAST ATTEMPT, THE REGISTRATION COULD BE COMPUTED CORRECTLY. IT INDICATES THAT THE DEVICE WORKED AS EXPECTED AND THAT THE ISSUE WAS CAUSED BY A USE ERROR. PATIENT CODE : 3191 - NO CODE AVAILABLE : THE EVENT DELAYED THE CASE BY MORE THAN 30 MINUTES." }, { "mdr_text_key": "312044141", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "THE SURGEON SENT TO THE FIELD SERVICE ENGINEER 2 PICTURES OF THE SCREEN OF THE ROBOT SHOWING THE ERROR VALUES OF THE INITIAL POINTS AND THE ERROR MESSAGE: THE REGISTRATION COULD NOT BE COMPUTED. DO YOU WANT TO PERFORM AGAIN THE REGISTRATION OR RETRY BY MODIFYING THE INITIAL POINTS? THE INITIALS POINTS WERE ALL RATED GREEN (CORRECT) ON THE RECOLLECTION OF INITIAL POINTS. THE SURGEON ASKED WHY EVERYTHING IS GREEN WHEREAS THE REGISTRATION IS NOT POSSIBLE. THE FSE ADVISED TO RETRY FIRST SETTING THE INITIAL POINTS AGAIN AND HAVE THE ERROR BELOW 2MM FOR EACH POINT. LATER, THE SURGEON INFORMED THE FSE THAT THE REGISTRATION WAS SUCCESSFUL." } ], "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": "03/08/2019" } ] }