{ "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": "3009185973-2019-00169", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20190521", "manufacturer_address_2": "", "pma_pmn_number": "K151359", "date_of_event": "20190423", "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": "20190521", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "422344", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20190521", "brand_name": "ROSA BRAIN", "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 BRAIN", "catalog_number": "N/A", "lot_number": "3.0.0.21", "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": "MN", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "01/20/2020", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250811", "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": "20190521", "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": "20200128", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "8626764", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20190423", "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": "317485918", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE SURGEON REPORTED THAT TRAJECTORY WAS SLIGHTLY INACCURATE COMPARED TO THE ONE INTENDED DURING THE PLANNING, AND THAT HE WAS DISSATISFIED WITH THE MERGING OF THE IMAGES. DHR REVIEW AND REVIEW OF COMPLAINT HISTORY DID NOT IDENTIFY ANY CONTRIBUTORY FACTORS TO THE EVENT. ACCORDING TO THE TECHNICAL INVESTIGATION, THE IMPLANT WAS INSERTED ACCURATELY (I.E. THE ERROR IS UNDER THE SPECIFICATION LIMIT), THE ROSA BRAIN DEVICE WORKED AS EXPECTED. FURTHERMORE, THE SURGEON WAS FRUSTRATED THAT THESE TWO FUSION MODES DID NOT WORK AS EXPECTED AND THAT MANUAL ADJUSTMENTS WERE TIME CONSUMING. AN OPTIMIZATION ALGORITHM IS USED TO COMPUTE THE FUSION, WHICH SOMETIMES MAY NOT PROVIDE SATISFYING RESULTS. FOR THIS REASON, ONCE AN AUTOMATIC, SEMIAUTOMATIC OR MANUAL FUSION HAS BEEN PERFORMED, A WINDOW APPEARS ALLOWING A USER VERIFICATION OF THE FUSION QUALITY AND MANUAL ADJUSTMENTS, IF NECESSARY. ANALYSIS OF THE POST-OPERATIVE FUSION REVEALED THAT THE IMPLANT WAS ACCURATELY INSERTED WITH RESPECT TO ITS PLANNING (THE ERROR IS MINIMAL AND UNDER THE 2MM SPECIFICATIONS LIMIT). ANALYSIS OF LOG FILES AND PATIENT FOLDER SHOWED THAT THE ACCURACY MEASUREMENT MIGHT HAVE BEEN IMPACTED BY: THE QUALITY OF THE PRE-OPERATIVE FUSION: THE USER ADJUSTED THE SUPERPOSITION OF THE MRI AND THE CT, BUT THE RESULT COULD STILL BE IMPROVED. THE QUALITY OF THE REGISTRATION: THE VERIFICATION STEP WAS NOT FOLLOWED AS RECOMMENDED IN THE SOFTWARE AND THE QUICK GUIDE. NONE OF THESE TWO HYPOTHESES COULD BE CONCLUSIVELY DETERMINED AS THE ROOT CAUSE OF THE ALLEGED INACCURACY. AS OUR ANALYSIS CONFIRMED THAT THE IMPLANT WAS INSERTED ACCURATELY (I.E. THE ERROR IS UNDER THE 2MM SPECIFICATION LIMIT), THE ROSA BRAIN DEVICE WORKED AS EXPECTED. CORRECTED DATA: B4 DATE OF THIS REPORT. G4 DATE RECEIVED BY MANUFACTURER. H2 IF FOLLOW-UP, WHAT TYPE . H3 DEVICE EVALUATED BY MANUFACTURER. H6 EVENT PROBLEM AND EVALUATION CODES." }, { "mdr_text_key": "317485919", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "SURGEON HAD A DIFFICULT TIME MERGING SCANS DURING THIS CASE. THE FIELD SERVICE ENGINEER (FSE) LOADED IN MRI BEFORE THE CASE AND THE SURGEON PLANNED 1 TRAJECTORY FOR ABLATION AND BIOPSY. SURGEON PINNED PATIENT IN A PRONE POSITION WITH THE HEAD TURNED SLIGHT LATERAL. HE PLACED FIDUCIALS, THEN TOOK AN O-ARM SPIN FOR REGISTRATION. HOWEVER, WHEN THE FSE AUTOMATICALLY MERGED THE O-ARM SCAN TO THE MRI, THE AUTOMATIC MERGE DID NOT WORK AND THE TWO SCANS WERE VERY OBVIOUSLY NOT MATCHED. THE SURGEON SPENT A WHILE TRYING TO GET THE TWO SCANS TO OVERLAP PERFECTLY USING THE MANUAL CONTROLS. HOWEVER, AFTER PERFORMING REGISTRATION AND DRIVING TO THE TRAJECTORY, THE SURGEON FELT THAT THE TRAJECTORY DID NOT LINE UP ANATOMICALLY ON THE PATIENT WITH THE PLANNED ANATOMICAL LOCATION. FSE SUGGESTED TRYING SEMI-AUTOMATIC MERGE BECAUSE THE AUTOMATIC MERGE DID NOT WORK CORRECTLY AND WAS HARD TO MANUALLY FIX. HOWEVER, TWO TRIES WITH SEMI-AUTOMATIC ACTUALLY HAD WORSE RESULTS THAN THE AUTOMATIC MERGE DID. FINALLY, THE SURGEON HAD TO USE AUTOMATIC MERGE AND THEN MANUALLY ADJUST AGAIN, AND THEN REDO REGISTRATION. THE TRAJECTORY ENDED UP BEING IN THE EXACT SAME SPOT, WHICH WAS STILL SLIGHTLY OFF FROM THE SURGEON¿S PLAN, BUT THE SURGEON DECIDED TO PROCEED. DELAY TO CASE WAS 45 MINUTES, PATIENT ALREADY UNDER ANESTHESIA, BEFORE FIRST INCISION, NO PATIENT IMPACT." }, { "mdr_text_key": "145603380", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "(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": "145603381", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "SURGEON HAD A DIFFICULT TIME MERGING SCANS DURING THIS CASE. THE FIELD SERVICE ENGINEER (FSE) LOADED IN MRI BEFORE THE CASE AND THE SURGEON PLANNED 1 TRAJECTORY FOR ABLATION AND BIOPSY. SURGEON PINNED PATIENT IN A PRONE POSITION WITH THE HEAD TURNED SLIGHT LATERAL. HE PLACED FIDUCIALS, THEN TOOK AN O-ARM SPIN FOR REGISTRATION. HOWEVER, WHEN THE FSE AUTOMATICALLY MERGED THE O-ARM SCAN TO THE MRI, THE AUTOMATIC MERGE DID NOT WORK AND THE TWO SCANS WERE VERY OBVIOUSLY NOT MATCHED. THE SURGEON SPENT A WHILE TRYING TO GET THE TWO SCANS TO OVERLAP PERFECTLY USING THE MANUAL CONTROLS. HOWEVER, AFTER PERFORMING REGISTRATION AND DRIVING TO THE TRAJECTORY, THE SURGEON FELT THAT THE TRAJECTORY DID NOT LINE UP ANATOMICALLY ON THE PATIENT WITH THE PLANNED ANATOMICAL LOCATION. FSE SUGGESTED TRYING SEMI-AUTOMATIC MERGE BECAUSE THE AUTOMATIC MERGE DID NOT WORK CORRECTLY AND WAS HARD TO MANUALLY FIX. HOWEVER, TWO TRIES WITH SEMI-AUTOMATIC ACTUALLY HAD WORSE RESULTS THAN THE AUTOMATIC MERGE DID. FINALLY, THE SURGEON HAD TO USE AUTOMATIC MERGE AND THEN MANUALLY ADJUST AGAIN, AND THEN REDO REGISTRATION. THE TRAJECTORY ENDED UP BEING IN THE EXACT SAME SPOT, WHICH WAS STILL SLIGHTLY OFF FROM THE SURGEON¿S PLAN, BUT THE SURGEON DECIDED TO PROCEED. DELAY TO CASE WAS 45 MINUTES, PATIENT ALREADY UNDER ANESTHESIA, BEFORE FIRST INCISION, NO PATIENT IMPACT." } ], "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": "01/29/2020" } ] }