{ "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": "3009185973-2020-00284", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20201106", "manufacturer_address_2": "", "pma_pmn_number": "K200511", "date_of_event": "20201016", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "003", "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": "20201106", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1264866", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "N", "date_received": "20201106", "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", "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": "3.1.4.1650", "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": "12/11/2020;06/16/2021", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250730", "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": "20201106", "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": "20210618", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10799643", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20201016", "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": "324976549", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "THE FOLLOWING EVENT OCCURRED DURING AN RNS CASE ON (B)(6) 2020: AT THE BEGINNING OF THE CASE, THE SURGEON PLACED THE LEKSELL FRAME ON THE PATIENT, AND THEN PROCEEDED TO PLACE 5 BONE FIDUCIALS FOR REGISTRATION. THE OR TEAM THEN TOOK THE PATIENT DOWN TO CT TO BE SCANNED AND THEN RETURNED TO THE OR. BECAUSE THE ROBOT IS NOT CONNECTED TO PACS (AS THEY USUALLY USE THE O-ARM) THE 0.625 BONE CT WAS LOADED ONTO THE PLANNING STATION AND MERGED TO THE PLAN THAT WAS CREATED PRE-OPERATIVELY. THE PLAN WAS THEN EXPORTED VIA USB TO THE ROBOT BY THE CLINICAL REPRESENTATIVE (CR). THE PATIENT WAS ATTACHED TO THE ROBOT VIA THE LEKSELL HEAD HOLDER (THE PATIENT WAS SLIGHTLY TILTED, BUT NOT IN A FULL BEACH CHAIR POSITION). REGISTRATION BEGAN AND THE 5 FIDUCIALS WERE REGISTERED. AT THIS POINT, THE RMS GENERATED AN ERROR THAT WAS >1.0. THE SURGEON THEN REGISTERED THE PATIENT AGAIN, REMOVING A FIDUCIAL SHE FELT WAS LOOSE GENERATING AN RMS OF GREATER THAN 3.0. BELIEVING THAT THERE WAS ANOTHER LOOSE FIDUCIAL, REGISTRATION WITH 3 FIDUCIALS WERE TRIED GIVING AN RMS OF GREATER THAN 8.0. AT THIS POINT, IN ORDER TO AVOID GOING TO CT AGAIN (AS THE O-ARM WAS ALSO BROKEN) THE SURGEON TRIED UTILIZING POINTS ON THE LEKSELL FRAME AS FIDUCIAL MARKERS TO REGISTER THE PATIENT (THE SURGEON WAS AWARE THIS IS CONSIDERED OFF-LABEL USAGE AS PER CONVERSATION WITH THE CR). AT THIS POINT, THE RMS WAS STILL GREATER THAN 1. A DIFFERENT FORMATTED CT SCAN WAS THEN MERGED ON THE LAPTOP TO THE PLAN (0.625 STD, AND THIS TIME MERGED TO A DIFFERENT MRI ¿ ALL SCANS IN THE PLAN HAD ALREADY BEEN MERGED PREVIOUSLY BY THE SURGEON DURING PLANNING) AND THEN TRANSFERRED TO THE LAPTOP. REGISTRATION WAS PERFORMED AGAIN, AND THE RMS WAS FINALLY UNDER 1 (0.82 MM). THE SURGEON COMPLAINED THAT THERE WAS NO ISSUE WITH THE 3 FIDUCIALS THAT WERE LEFT IN AND SAID SHE HAD NEVER SEEN THE RMS GIVE SUCH AN ERROR PREVIOUSLY. THE DELAY WAS 45 MINUTES." }, { "mdr_text_key": "324976550", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "A DETAILED ANALYSIS OF THE DATA LOGS HAS BEEN PERFORMED, AND THIS ANALYSIS DID NOT PERMIT TO FIND A ROOT CAUSE FOR THE HIGH RMS VALUES OBTAINED DURING THE CASE. THE POSITION ERROR OF THE ROBOT MARKERS IN REGARD TO THE IMAGE MARKERS IS NOT CONSISTENT WITH A MOVEMENT OF THE HEAD." }, { "mdr_text_key": "215276974", "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. UNIQUE IDENTIFIER (UDI) #: (B)(4)." }, { "mdr_text_key": "215276975", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THE FOLLOWING EVENT OCCURRED DURING AN RNS CASE ON (B)(6) 2020: AT THE BEGINNING OF THE CASE, THE SURGEON PLACED THE LEKSELL FRAME ON THE PATIENT, AND THEN PROCEEDED TO PLACE 5 BONE FIDUCIALS FOR REGISTRATION. THE OR TEAM THEN TOOK THE PATIENT DOWN TO CT TO BE SCANNED AND THEN RETURNED TO THE OR. BECAUSE THE ROBOT IS NOT CONNECTED TO PACS (AS THEY USUALLY USE THE O-ARM) THE 0.625 BONE CT WAS LOADED ONTO THE PLANNING STATION AND MERGED TO THE PLAN THAT WAS CREATED PRE-OPERATIVELY. THE PLAN WAS THEN EXPORTED VIA USB TO THE ROBOT BY THE CLINICAL REPRESENTATIVE (CR). THE PATIENT WAS ATTACHED TO THE ROBOT VIA THE LEKSELL HEAD HOLDER (THE PATIENT WAS SLIGHTLY TILTED, BUT NOT IN A FULL BEACH CHAIR POSITION). REGISTRATION BEGAN AND THE 5 FIDUCIALS WERE REGISTERED. AT THIS POINT, THE RMS GENERATED AN ERROR THAT WAS >1.0. THE SURGEON THEN REGISTERED THE PATIENT AGAIN, REMOVING A FIDUCIAL SHE FELT WAS LOOSE GENERATING AN RMS OF GREATER THAN 3.0. BELIEVING THAT THERE WAS ANOTHER LOOSE FIDUCIAL, REGISTRATION WITH 3 FIDUCIALS WERE TRIED GIVING AN RMS OF GREATER THAN 8.0. AT THIS POINT, IN ORDER TO AVOID GOING TO CT AGAIN (AS THE O-ARM WAS ALSO BROKEN) THE SURGEON TRIED UTILIZING POINTS ON THE LEKSELL FRAME AS FIDUCIAL MARKERS TO REGISTER THE PATIENT (THE SURGEON WAS AWARE THIS IS CONSIDERED OFF-LABEL USAGE AS PER CONVERSATION WITH THE CR). AT THIS POINT, THE RMS WAS STILL GREATER THAN 1. A DIFFERENT FORMATTED CT SCAN WAS THEN MERGED ON THE LAPTOP TO THE PLAN (0.625 STD, AND THIS TIME MERGED TO A DIFFERENT MRI ¿ ALL SCANS IN THE PLAN HAD ALREADY BEEN MERGED PREVIOUSLY BY THE SURGEON DURING PLANNING) AND THEN TRANSFERRED TO THE LAPTOP. REGISTRATION WAS PERFORMED AGAIN, AND THE RMS WAS FINALLY UNDER 1 (0.82 MM). THE SURGEON COMPLAINED THAT THERE WAS NO ISSUE WITH THE 3 FIDUCIALS THAT WERE LEFT IN AND SAID SHE HAD NEVER SEEN THE RMS GIVE SUCH AN ERROR PREVIOUSLY. THE DELAY WAS 45 MINUTES." }, { "mdr_text_key": "321741307", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "THE FOLLOWING EVENT OCCURRED DURING AN RNS CASE ON (B)(6) 2020: AT THE BEGINNING OF THE CASE, THE SURGEON PLACED THE LEKSELL FRAME ON THE PATIENT, AND THEN PROCEEDED TO PLACE 5 BONE FIDUCIALS FOR REGISTRATION. THE OR TEAM THEN TOOK THE PATIENT DOWN TO CT TO BE SCANNED AND THEN RETURNED TO THE OPERATING ROOM (OR). BECAUSE THE ROBOT IS NOT CONNECTED TO PACS (AS THEY USUALLY USE THE O-ARM) THE 0.625 BONE CT WAS LOADED ONTO THE PLANNING STATION AND MERGED TO THE PLAN THAT WAS CREATED PRE-OPERATIVELY. THE PLAN WAS THEN EXPORTED VIA USB TO THE ROBOT BY THE CLINICAL REPRESENTATIVE (CR). THE PATIENT WAS ATTACHED TO THE ROBOT VIA THE LEKSELL HEAD HOLDER (THE PATIENT WAS SLIGHTLY TILTED, BUT NOT IN A FULL BEACH CHAIR POSITION). REGISTRATION BEGAN AND THE 5 FIDUCIALS WERE REGISTERED. AT THIS POINT, THE RMS GENERATED AN ERROR THAT WAS >1.0. THE SURGEON THEN REGISTERED THE PATIENT AGAIN, REMOVING A FIDUCIAL SHE FELT WAS LOOSE GENERATING AN RMS OF GREATER THAN 3.0. BELIEVING THAT THERE WAS ANOTHER LOOSE FIDUCIAL, REGISTRATION WITH 3 FIDUCIALS WERE TRIED GIVING AN RMS OF GREATER THAN 8.0. AT THIS POINT, IN ORDER TO AVOID GOING TO CT AGAIN (AS THE O-ARM WAS ALSO BROKEN) THE SURGEON TRIED UTILIZING POINTS ON THE LEKSELL FRAME AS FIDUCIAL MARKERS TO REGISTER THE PATIENT (THE SURGEON WAS AWARE THIS IS CONSIDERED OFF-LABEL USAGE AS PER CONVERSATION WITH THE CR). AT THIS POINT, THE RMS WAS STILL GREATER THAN 1. A DIFFERENT FORMATTED CT SCAN WAS THEN MERGED ON THE LAPTOP TO THE PLAN (0.625 STD, AND THIS TIME MERGED TO A DIFFERENT MRI ¿ ALL SCANS IN THE PLAN HAD ALREADY BEEN MERGED PREVIOUSLY BY THE SURGEON DURING PLANNING) AND THEN TRANSFERRED TO THE LAPTOP. REGISTRATION WAS PERFORMED AGAIN, AND THE RMS WAS FINALLY UNDER 1 (0.82 MM). THE SURGEON COMPLAINED THAT THERE WAS NO ISSUE WITH THE 3 FIDUCIALS THAT WERE LEFT IN AND SAID SHE HAD NEVER SEEN THE RMS GIVE SUCH AN ERROR PREVIOUSLY. THE DELAY WAS 45 MINUTES." }, { "mdr_text_key": "321741308", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "A FULL ANALYSIS OF THE DATA LOGS HAS BEEN PERFORMED ANS THIS ANALYSIS CONCLUDED THAT THE UNSATISFYING RMS VALUES WERE DUE TO AN INCORRECT MERGE OF THE PRE-OPERATIVE CT WITH THE MRI. WHEN THE SAME CT WITH A BETTER CONTRAST WAS MERGED AGAIN, THE RESULT WAS CORRECT AND THE RMS VALUES OBTAINED WERE SATISFACTORY. A REVIEW OF THE IFUS WAS PERFORMED AND THE USER MANUAL ADEQUATELY INDICATES THE NECESSARY INFORMATION FOR THE USER TO CORRECTLY VERIFY THE FUSION." } ], "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": "12/15/2020;06/18/2021" } ] }