{ "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": "3009185973-2019-00290", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20190823", "manufacturer_address_2": "", "pma_pmn_number": "K151359", "date_of_event": "20190725", "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": "20190823", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "721129", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20190823", "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", "Imprecision", "Computer Software Problem", "Imprecision" ], "reporter_state_code": "MA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "01/22/2020", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250815", "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": "20190823", "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": "8925141", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20190725", "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": "316968339", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT REGISTRATION HAD TO BE PERFORMED MULTIPLE TIMES BECAUSE IT WAS NOT SATISFYING. IT WAS ALSO REPORTED THAT SOME ELECTRODES WERE FOUND TO BE PLACED INACCURATELY. DHR REVIEW AND REVIEW OF COMPLAINT HISTORY DID NOT IDENTIFY ANY CONTRIBUTORY FACTORS TO THE EVENT. ACCORDING TO TECHNICAL INVESTIGATION THE DIFFICULTY OF REGISTRATION CANNOT BE CONFIRMED BY THE LOG ANALYSIS. THEN, ANALYSIS OF POST-OPERATIVE FUSION REVEALED THAT SIX OUT OF THE FOURTEEN ELECTRODES IMPLANTED HAD BEEN INSERTED BETWEEN 2.48 MM AND 3.80 MM AWAY FROM THEIR PLANNED ENTRY POINTS. ANALYSIS OF DEVIATION SHOWS THAT THE INACCURACY CASE WAS NOT DUE TO A SINGLE CAUSE, BUT MIGHT HAVE BEEN IMPACTED BY THE IMAGE FUSION QUALITY OF PRE AND POST-OPERATIVE FUSIONS AND/OR AN UNDETECTED HEAD SHIFT AFTER THE REGISTRATION. NONE OF THESE TWO HYPOTHESIS COULD BE CONFIRMED WITH AVAILABLE INFORMATION THEN, THE ROOT CAUSE FOR THIS INACCURACY CASE CANNOT BE DETERMINED. CORRECTED DATA: B4: DATE OF THIS REPORT. D4: ADDITIONAL DEVICE INFORMATION: SERIAL NUMBER. 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": "316968340", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "STARTING AROUND 9AM EST, THE FIRST OF THREE LASER REGISTRATIONS WERE PERFORMED. EACH VERIFICATION SHOWED THE REGISTRATION TO BE UNSATISFACTORY AT POINTS NEAR THE OUTER CANTHI AND THE SKIN LATERAL TO THE OUTER CANTHI. ALL OTHER POINTS ON THE SKIN SURFACE (FOREHEAD, NASION, TEMPLES, ETC.) SHOWED SATISFACTORY RESULTS, BUT SINCE SOME TRAJECTORIES WERE PLANNED NEAR THE UNSATISFACTORY AREA, THE SURGEON DID NOT FEEL COMFORTABLE WITH MOVING FORWARD WITH ANY OF THE REGISTRATIONS. THE CT SCAN BEING USED WAS RECENT, AND THE 3D SEGMENTED MODEL APPEARED TO BE CLEAR AND CORRECT. THE MANUAL SCANS LOOKED GOOD FOR EACH REGISTRATION. WHEN PICKING THE INITIAL POINTS ON THE FACE AND TRYING TO MATCH THE POINTS WITH THE LASER, THE POINTS AT THE OUTER CANTHI ALWAYS SHOWED TO BE INSIDE THE 3D MODEL (INSIDE THE SKIN BY ABOUT 2MM). SINCE THIS WAS LESS THAN 2.9MM, THE RESULTS WOULD BE GREEN AND THE REGISTRATION WOULD BE MOVED FORWARD. NO MATTER HOW MANY TIMES THE OUTER CANTHI POINTS WERE ATTEMPTED WITH THE LASER, IT ALWAYS SHOWED TO BE INSIDE THE SKIN. AFTER THE THREE ATTEMPTS, SURGEON SWITCHED TO BONE FIDUCIALS, AND AN RMS OF 0.78MM WAS ACQUIRED. AFTER VERIFICATION, SURGEON WAS OKAY WITH MOVING FORWARD. AFTER ALL LEADS HAD BEEN PLACED, A POST-OP SCAN WAS ACQUIRED AND MERGED TO THE PRE-OP PLAN AROUND 4:30PM EST. THE MERGE APPEARED TO BE CORRECT, AND IT WAS NOTICED THAT SOME ELECTRODES APPEARED TO BE ACCURATE, WHILE OTHERS APPEARED TO BE OFF BY OVER 2MM." }, { "mdr_text_key": "155335518", "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": "155335519", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "STARTING AROUND 9AM EST, THE FIRST OF THREE LASER REGISTRATIONS WERE PERFORMED. EACH VERIFICATION SHOWED THE REGISTRATION TO BE UNSATISFACTORY AT POINTS NEAR THE OUTER CANTHI AND THE SKIN LATERAL TO THE OUTER CANTHI. ALL OTHER POINTS ON THE SKIN SURFACE (FOREHEAD, NASION, TEMPLES, ETC.) SHOWED SATISFACTORY RESULTS, BUT SINCE SOME TRAJECTORIES WERE PLANNED NEAR THE UNSATISFACTORY AREA, THE SURGEON DID NOT FEEL COMFORTABLE WITH MOVING FORWARD WITH ANY OF THE REGISTRATIONS. THE CT SCAN BEING USED WAS RECENT, AND THE 3D SEGMENTED MODEL APPEARED TO BE CLEAR AND CORRECT. THE MANUAL SCANS LOOKED GOOD FOR EACH REGISTRATION. WHEN PICKING THE INITIAL POINTS ON THE FACE AND TRYING TO MATCH THE POINTS WITH THE LASER, THE POINTS AT THE OUTER CANTHI ALWAYS SHOWED TO BE INSIDE THE 3D MODEL (INSIDE THE SKIN BY ABOUT 2MM). SINCE THIS WAS LESS THAN 2.9MM, THE RESULTS WOULD BE GREEN AND THE REGISTRATION WOULD BE MOVED FORWARD. NO MATTER HOW MANY TIMES THE OUTER CANTHI POINTS WERE ATTEMPTED WITH THE LASER, IT ALWAYS SHOWED TO BE INSIDE THE SKIN. AFTER THE THREE ATTEMPTS, SURGEON SWITCHED TO BONE FIDUCIALS, AND AN RMS OF 0.78MM WAS ACQUIRED. AFTER VERIFICATION, SURGEON WAS OKAY WITH MOVING FORWARD. AFTER ALL LEADS HAD BEEN PLACED, A POST-OP SCAN WAS ACQUIRED AND MERGED TO THE PRE-OP PLAN AROUND 4:30PM EST. THE MERGE APPEARED TO BE CORRECT, AND IT WAS NOTICED THAT SOME ELECTRODES APPEARED TO BE ACCURATE, WHILE OTHERS APPEARED TO BE OFF BY OVER 2MM." } ], "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": "01/31/2020" } ] }