{ "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": "3009185973-2020-00078", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20200304", "manufacturer_address_2": "", "pma_pmn_number": "K182417", "date_of_event": "20200302", "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": "20200304", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "248435", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20200304", "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", "catalog_number": "ROSAS00203", "lot_number": "3.1.1.1295", "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": [ "Adverse Event Without Identified Device or Use Problem", "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "MD", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "08/03/2020", "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": "20200304", "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": "20200805", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "9785341", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20200302", "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": "193014801", "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. (B)(4)." }, { "mdr_text_key": "193014802", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "A DBS PROCEDURE WAS BEING PERFORMED. MARKER REGISTRATION OCCURRED WITH 5 FIDUCIALS AND THE RMS OF THE REGISTRATION WAS 0.86MM. AFTER, REGISTRATION AND VERIFICATION, THE FIDUCIALS WERE REMOVED BECAUSE THEY WERE IN THE WAY OF THE OPERATING AREA. AT THE FIRST TRAJECTORY TARGETING THE VIM, THERE WERE GOOD RESULTS WITH THE MICROELECTRODE RECORDINGS. THE SURGICAL TEAM THEN DECIDED TO TARGET A SLIGHTLY ADJACENT AREA OF THE VIM FOR A 'SECOND RUN'. DURING THIS RUN, THE PHYSICAL RESPONSE THAT THE PATIENT HAD TO THE STIMULUS MADE THE PATIENT UNCOMFORTABLE. THIS DISCOMFORT LED TO THE PATIENT TRYING TO SHIFT THEIR WEIGHT IN THE SURGICAL BED (THE PATIENT WAS AWAKE DURING THIS TESTING) AND THUS LEADING TO THE SHIFT IN THE HEAD FRAME. THIS CAUSED FUTURE INACCURACIES TO AROUND 3-4MM, HOWEVER THERE WAS NO PERMANENT LEAD PLACED. THESE INACCURACIES WERE FOUND DURING AN INTEROPERATIVE CT SCAN. UPON DISCOVERY, MULTIPLE FACTORS WERE CHECKED (IE: MERGING, REGISTRATION, TOOLS/INSTRUMENTS USED) AND THE SURGEON DISCOVERED THAT THE LEKSELL FRAME ON THE PATIENT HAD ACTUALLY LOOSENED WHEN SHE WAS MOVING AND THUS CAUSED THE INACCURACY. ONCE THIS DISCOVERY WAS MADE, THE SURGEON AND THE STAFF ABORTED THE CASE." }, { "mdr_text_key": "319582931", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "AN ANALYSIS OF THE DATA LOGS AND PATIENT FOLDER HAS BEEN PERFORMED. THIS ANALYSIS CONCLUDED THAT THE INACCURACY IS CONFIRMED FOR THE LEAD WHICH WAS IMPLANTED 6.83MM AWAY OF THE PLANNED TRAJECTORY. THE ANALYSIS REVEALED THAT THE FUSION AND REGISTRATION WERE CORRECT AND THAT: - A KNOWN SOFTWARE ANOMALY OCCURRED DURING THE REGISTRATION BUT HAS NO IMPACT ON REGISTRATION ACCURACY. - THE RECOMMENDED POINTS WERE NOT VERIFIED AND ONE POINT WAS VERIFIED WHEREAS THE SOFTWARE INFORMED THAT A SIGNIFICANT ERROR WAS DETECTED. - THE LEAD WAS RELOCATED ON PURPOSE NEAR TO THE ORIGINAL TRAJECTORY FOR THE SECOND STIMULATION USING A DIFFERENT GUIDE TUBE. - THE LEKSELL FRAME LOOSENING WHICH PROBABLY ALLOWED THE PATIENT HEAD SHIFT, WAS FOUND AFTER THE SECOND STIMULATION. BASED ON THE INVESTIGATION PERFORMED, THE CAUSE FOR THE INACCURACY ISSUE IS UNDETERMINED AND IT HAS NOT BEEN ESTABLISHED WHETHER IT IS SUBSEQUENT TO THE PATIENT MOVEMENT FOLLOWING THE SECOND STIMULATION. THE WORKFLOW OF THE CASE CONTAINS TWO POTENTIAL USER ERRORS: - THE VERIFICATION WAS NOT PERFORMED PROPERLY. - NO VERIFICATION WAS PERFORMED AFTER THE SUSPECTED HEAD MOVEMENT AND THE REGISTRATION WAS NOT RESTARTED WHICH LED TO THE SURGERY ABORTION. THE USER MANUAL CONTAINS THE CORRECT RECOMMENDATIONS TO PERFORM THE VERIFICATION STEP OF REGISTRATION. THE VERIFICATION IN THIS CASE WAS NOT MADE ON RECOMMENDED ANATOMICAL POINTS AND TWO IMPORTANT ERRORS WERE VALIDATED. ONE WAS DUE TO A SOFTWARE ANOMALY, THE OTHER WAS AN ACTUAL ERROR OVER THRESHOLD. A HEAD MOTION WAS FOUND AFTER THE VERIFICATION OF THE PATIENT IMMOBILIZATION CHAIN. IN CASE OF HEAD MOTION SUSPICION OR CONFIRMATION, THE USER MANUAL ALSO SPECIFIES TO RESTART REGISTRATION. IN THIS CASE, AFTER THE HEAD MOTION CONFIRMATION, THE SURGEON DECIDED TO ABORT THE OPERATION." }, { "mdr_text_key": "319582932", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "A DBS PROCEDURE WAS BEING PERFORMED. MARKER REGISTRATION OCCURRED WITH 5 FIDUCIALS AND THE RMS OF THE REGISTRATION WAS 0.86MM. AFTER, REGISTRATION AND VERIFICATION, THE FIDUCIALS WERE REMOVED BECAUSE THEY WERE IN THE WAY OF THE OPERATING AREA. AT THE FIRST TRAJECTORY TARGETING THE VIM, THERE WERE GOOD RESULTS WITH THE MICROELECTRODE RECORDINGS. THE SURGICAL TEAM THEN DECIDED TO TARGET A SLIGHTLY. ADJACENT AREA OF THE VIM FOR A 'SECOND RUN'. DURING THIS RUN, THE PHYSICAL RESPONSE THAT THE PATIENT HAD TO THE STIMULUS MADE THE PATIENT UNCOMFORTABLE. THIS DISCOMFORT LED TO THE PATIENT TRYING TO SHIFT THEIR WEIGHT IN THE SURGICAL BED (THE PATIENT WAS AWAKE DURING THIS TESTING) AND THUS LEADING TO THE SHIFT IN THE HEAD FRAME. THIS CAUSED FUTURE INACCURACIES TO AROUND 3-4MM, HOWEVER THERE WAS NO PERMANENT LEAD PLACED. THESE INACCURACIES WERE FOUND DURING AN INTEROPERATIVE CT SCAN. UPON DISCOVERY, MULTIPLE FACTORS WERE CHECKED (IE: MERGING, REGISTRATION, TOOLS/INSTRUMENTS USED) AND THE SURGEON DISCOVERED THAT THE LEKSELL FRAME ON THE PATIENT HAD ACTUALLY LOOSENED WHEN SHE WAS MOVING AND THUS CAUSED THE INACCURACY. ONCE THIS DISCOVERY WAS MADE, THE SURGEON AND THE STAFF ABORTED THE CASE." } ], "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": "08/06/2020" } ] }