{ "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": "3009185973-2021-00047", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20210218", "manufacturer_address_2": "", "pma_pmn_number": "K200511", "date_of_event": "20210120", "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": "20210218", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "240325", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "U", "date_received": "20210218", "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 3.1", "catalog_number": "ROSAS00203", "lot_number": "3.1.4.1650", "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": "CA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "05/21/2021", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250729", "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": "20210218", "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 Consequences Or Impact To Patient" ] } ], "distributor_city": "", "date_report": "20210521", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "11344191", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20210120", "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": "232792098", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "UDI# : (B)(4). THE DEVICE HAS NOT BEEN EVALUATED YET FOR INVESTIGATION PURPOSE. ONCE THE EVALUATION IS PERFORMED, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED." }, { "mdr_text_key": "232792099", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AT 10:45 AM, THE ROBOT ARM WAS DRIFTING WHEN IN AXIAL AND FREE AND FAST (WHERE THE ARM WAS MOVING ON ITS OWN WITHOUT TACTILE INTERACTION FROM THE USER). AFTER THE FIRST ELECTRODE, THE SURGEON CHECKED THE BONE FIDUCIAL PLACEMENT BY MAKING A TRAJECTORY AND DRIVING THERE, AND THE TRAJECTORY TO THE BONE FIDUCIAL APPEARED TO BE ABOUT 1 MM OFF SO THE ROBOT WAS UNDRAPED, THE PATIENT WAS RE-REGISTERED AND THE ROBOT WAS RE-DRAPED. AT THAT POINT, EVERYTHING WAS ACCURATE FOR THE REST OF THE CASE AND NO DRIFTING. THERE COULD HAVE BEEN A CALIBRATION ISSUE WHEN THE SURGEON CALIBRATED THE INSTRUMENT HOLDER THE FIRST TIME. INITIALLY THE USER USED INSTRUMENT HOLDER MT-02- 158 (B)(4) THEN AFTERWARDS WHEN WE RE-DRAPED THE USER USED MT-2-158 (B)(4). THIS CAUSED ABOUT A 30-MINUTE DELAY." }, { "mdr_text_key": "324975082", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "AT ~10:45 AM, THE ROBOT ARM WAS DRIFTING WHEN IN AXIAL AND FREE AND FAST (WHERE THE ARM WAS MOVING ON ITS OWN WITHOUT TACTILE INTERACTION FROM THE USER). AFTER THE FIRST ELECTRODE, THE SURGEON CHECKED THE BONE FIDUCIAL PLACEMENT BY MAKING A TRAJECTORY AND DRIVING THERE, AND THE TRAJECTORY TO THE BONE FIDUCIAL APPEARED TO BE ABOUT 1 MM OFF SO THE ROBOT WAS UNDRAPED, THE PATIENT WAS RE-REGISTERED AND THE ROBOT WAS RE-DRAPED. AT THAT POINT, EVERYTHING WAS ACCURATE FOR THE REST OF THE CASE AND NO DRIFTING. THERE COULD HAVE BEEN A CALIBRATION ISSUE WHEN THE SURGEON CALIBRATED THE INSTRUMENT HOLDER THE FIRST TIME. INITIALLY THE USER USED INSTRUMENT HOLDER MT-02- 158 S18096 THEN AFTERWARDS WHEN WE RE-DRAPED THE USER USED MT-2-158 S18238. THIS CAUSED ABOUT A 30-MINUTE DELAY." }, { "mdr_text_key": "324975083", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "DHR REVIEW AND REVIEW OF COMPLAINT HISTORY DID NOT IDENTIFY ANY CONTRIBUTORY FACTORS TO THE EVENT. A FULL ANALYSIS OF THE DATA LOGS HAS BEEN PERFORMED AND CONCLUDED THAT THE DRIFT COULD OCCUR AS A CALIBRATION FAILURE WAS DETECTED BEFORE TO RESTART THE REGISTRATION. IT IS CONFIRMED THAT AFTER THE REBOOT, THE EMPTY CALIBRATION WAS NOT PERFORMED PROPERLY. IT IS THE CAUSE FOR THE REPORTED ARM DRIFT. IT IS ASSUMED THAT AN INSTRUMENT OR AN EFFORT WAS APPLIED ON THE FORCE SENSOR WHEN THE EMPTY CALIBRATION WAS LAUNCHED AGAIN BUT THIS CANNOT BE CONFIRMED. NO OTHER SIMILAR EVENT WAS REPORTED DURING THE FOLLOWING CASES AND PREVENTIVE MAINTENANCE PERFORMED SINCE THEN." } ], "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": "06/04/2021" } ] }