{ "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": "3009185973-2021-00124", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20210514", "manufacturer_address_2": "", "pma_pmn_number": "K200511", "date_of_event": "20210506", "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": "20210514", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "721452", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "U", "date_received": "20210514", "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": "MI", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "05/20/2021", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250810", "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": "20210514", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Clinical Signs, Symptoms or Conditions", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20210604", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "11824138", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20210506", "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": "324260643", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "A DETAILED ANALYSIS OF THE DATA LOGS HAS BEEN PERFORMED AND THIS ANALYSIS REVEALED THAT THE INACCURACY BETWEEN 4MM AND 5MM AT THE ENTRY POINT WAS CONFIRMED FOR BOTH LEADS. HOWEVER, THE ROOT CAUSE FOR THIS INACCURACY REMAINS UNKNOWN. THE REGISTRATION AND FUSIONS WERE PERFORMED CORRECTLY, AND NO DYSFUNCTION WAS FOUND WITH THE ROSA DEVICE; IT PASSED THE PREVIOUS MAINTENANCE TESTS. IT SHOULD BE NOTED THAT THE HEAD HOLDER USED (NORAS) IS NOT PART OF THE LIST OF ROSA COMPATIBLE DEVICES. MOREOVER, THE HEAD HOLDER WAS NOT CONNECTED TO THE SUPPORT ARM OF THE ROSA DEVICE, AS RECOMMENDED IN THE IFUS; INSTEAD, IT WAS CONNECTED TO THE PATIENT'S BED, AS REPORTED. AFTER RE-PERFORMING REGISTRATION USING BONE FIDUCIALS AND PLANNING A NEW TRAJECTORY, THE SURGERY PROCEEDED WITH NO ISSUE. CORRECTED DATA: B4: DATE OF THIS REPORT. D4: LOT NUMBER. G3: DATE RECEIVED BY MANUFACTURER. H2: IF FOLLOW-UP, WHAT TYPE. H3: DEVICE EVALUATED BY MANUFACTURER. H6: ADVERSE EVENT PROBLEM. H10: ADDITIONAL NARRATIVES/DATA." }, { "mdr_text_key": "324260644", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "THE CLINICAL REPRESENTATIVE (CR) ASSISTED THE SURGEON FOR AN ABLATION/BIOPSY CASE. CONTACTLESS REGISTRATION WAS PERFORMED, AND ACCURACY APPEARED TO BE GOOD. VERIFICATION LOOKED GREAT, SO SURGERY WAS STARTED. AFTER VERIFICATION, THE SURGEON MARKED THE ENTRY POINTS USING A MARKER AND THE LASER. AFTER DRAPING THE PATIENT AND GOING TO THE FIRST TRAJECTORY WITH THE DRILL ADAPTOR, THE SURGEON NOTICED THAT THE POINT OF THE DRILL ADAPTOR APPEARED TO BE MISSING THE MARK MADE ON THE PATIENT SKIN BY ABOUT 4-5MM. THE SURGEON WASN'T SURE IF THE LOCAL ANESTHESIA THAT WAS APPLIED TO THE AREA WAS CAUSING THE SKIN TO DEFORM, OR IF MAYBE THE DRAPING ON THE PATIENTS HEAD WAS PULLING THE SKIN SLIGHTLY TO SHOW THIS ISSUE. THE SURGEON AND CR DID NOT NOTICE ANY HEAD-SHIFT. THE SURGEON DECIDED TO PROCEED AND PLACE THE BOLTS FOR THE LEADS (TRAJECTORY 1 AND 2). AFTER PLACING THE BOLTS, THE SURGEON DIDN'T FEEL CONFIDENT THEY WERE PLACED CORRECTLY, SO THE SURGEON PLACED THE LEADS INTO THE BOLT, BUT JUST A CENTIMETER OR SO INTO THE BRAIN TO GET AN IDEA IF THE BOLTS WERE PLACED CORRECTLY. AROUND 9:57AM EASTERN TIME, THE POST-OP SCAN WAS MERGED, AND IT WAS CONFIRMED THAT THE BOLTS FOR EACH TRAJECTORY WERE AROUND 4MM OFF AT ENTRY. THE SURGEON DECIDED THAT IF THE ABLATION LEADS WERE PLACED TO TARGET, THEN THERE COULD HAVE BEEN SOME ISSUES WITH VESSELS, SO THE INSERTION OF THE LEADS WERE ABORTED. THERE WERE NO VISIBLE ISSUES CAUSED BY THE INCORRECT PLACEMENT OF THE BOLTS AND LEADS. THE SURGEON DECIDED TO RE-PLAN A NEW TRAJECTORY (TRAJECTORY 5) AND JUST PLACE THE NEW TRAJECTORY, BUT ONLY IF THEY FELT THE ACCURACY WAS GOOD ENOUGH. THE REGISTRATION HAD TO BE RE-PERFORMED, BUT THIS TIME BONE FIDUCIALS WERE USED FOR REGISTRATION. THE SURGEON PLACED THE BOLT AND LEAD, AND THE POST-OP IMAGING WAS OBTAINED AND MERGED TO THE PLAN. THE POST-OP SHOWED THAT THE ACCURACY WAS GOOD, AND THE ABLATION COULD BE PROCEEDED WITH. THE SURGEON AND CR BOTH DO NOT BELIEVE THERE WAS ANY HEAD SHIFT FOR THE FIRST INSTANCE, BUT IT'S POSSIBLE SOMETHING WAS MISSED IF NOTHING ELSE IS FOUND IN THE LOGS. THE PATIENT WAS UNDER ANESTHESIA AND INCISION WAS MADE. TOTAL DELAY WAS OVER AN HOUR SINCE THE CASE NEEDED TO BE RESTARTED." }, { "mdr_text_key": "250610480", "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": "250610481", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THE CLINICAL REPRESENTATIVE (CR) ASSISTED THE SURGEON FOR AN ABLATION/BIOPSY CASE. CONTACTLESS REGISTRATION WAS PERFORMED, AND ACCURACY APPEARED TO BE GOOD. VERIFICATION LOOKED GREAT, SO SURGERY WAS STARTED. AFTER VERIFICATION, THE SURGEON MARKED THE ENTRY POINTS USING A MARKER AND THE LASER. AFTER DRAPING THE PATIENT AND GOING TO THE FIRST TRAJECTORY WITH THE DRILL ADAPTOR, THE SURGEON NOTICED THAT THE POINT OF THE DRILL ADAPTOR APPEARED TO BE MISSING THE MARK MADE ON THE PATIENT SKIN BY ABOUT 4-5MM. THE SURGEON WASN'T SURE IF THE LOCAL ANESTHESIA THAT WAS APPLIED TO THE AREA WAS CAUSING THE SKIN TO DEFORM, OR IF MAYBE THE DRAPING ON THE PATIENTS HEAD WAS PULLING THE SKIN SLIGHTLY TO SHOW THIS ISSUE. THE SURGEON AND CR DID NOT NOTICE ANY HEAD-SHIFT. THE SURGEON DECIDED TO PROCEED AND PLACE THE BOLTS FOR THE LEADS (TRAJECTORY 1 AND 2). AFTER PLACING THE BOLTS, THE SURGEON DIDN'T FEEL CONFIDENT THEY WERE PLACED CORRECTLY, SO THE SURGEON PLACED THE LEADS INTO THE BOLT, BUT JUST A CENTIMETER OR SO INTO THE BRAIN TO GET AN IDEA IF THE BOLTS WERE PLACED CORRECTLY. AROUND 9:57AM EASTERN TIME, THE POST-OP SCAN WAS MERGED, AND IT WAS CONFIRMED THAT THE BOLTS FOR EACH TRAJECTORY WERE AROUND 4MM OFF AT ENTRY. THE SURGEON DECIDED THAT IF THE ABLATION LEADS WERE PLACED TO TARGET, THEN THERE COULD HAVE BEEN SOME ISSUES WITH VESSELS, SO THE INSERTION OF THE LEADS WERE ABORTED. THERE WERE NO VISIBLE ISSUES CAUSED BY THE INCORRECT PLACEMENT OF THE BOLTS AND LEADS. THE SURGEON DECIDED TO RE-PLAN A NEW TRAJECTORY (TRAJECTORY 5) AND JUST PLACE THE NEW TRAJECTORY, BUT ONLY IF THEY FELT THE ACCURACY WAS GOOD ENOUGH. THE REGISTRATION HAD TO BE RE-PERFORMED, BUT THIS TIME BONE FIDUCIALS WERE USED FOR REGISTRATION. THE SURGEON PLACED THE BOLT AND LEAD, AND THE POST-OP IMAGING WAS OBTAINED AND MERGED TO THE PLAN. THE POST-OP SHOWED THAT THE ACCURACY WAS GOOD, AND THE ABLATION COULD BE PROCEEDED WITH. THE SURGEON AND CR BOTH DO NOT BELIEVE THERE WAS ANY HEAD SHIFT FOR THE FIRST INSTANCE, BUT IT'S POSSIBLE SOMETHING WAS MISSED IF NOTHING ELSE IS FOUND IN THE LOGS. THE PATIENT WAS UNDER ANESTHESIA AND INCISION WAS MADE. TOTAL DELAY WAS OVER AN HOUR SINCE THE CASE NEEDED TO BE RESTARTED." } ], "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" } ] }