{ "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": "3009185973-2020-00199", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20200903", "manufacturer_address_2": "", "pma_pmn_number": "K182417", "date_of_event": "20200810", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "BIOMEDICAL ENGINEER", "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": "20200903", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "953412", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20200903", "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": [ "Incorrect, Inadequate or Imprecise Result or Readings", "Incorrect, Inadequate or Imprecise Result or Readings" ], "reporter_state_code": "IL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "01/25/2021", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250814", "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": "20200903", "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": "20210129", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10489136", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20200810", "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": "322266061", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "A FULL ANALYSIS OF THE DATA LOGS HAS BEEN PERFORMED. THIS ANALYSIS CONCLUDED THAT ALTHOUGH THE HEAD HOLDER WAS FOUND UNTIGHTENED AFTER THE FIRST INTRA-OPERATIVE CT, THE ELECTRODES WERE ACCURATELY IMPLANTED. REVIEW OF THE PATIENT FOLDER FOUND OUT THAT TWO TRAJECTORIES WERE PLANNED 2MM FROM EACH OTHER AND WERE PARTIALLY SUPERIMPOSED. THE FINAL POST-OPERATIVE CT SCAN INDICATED THAT THE CORRESPONDING ELECTRODE WAS NOT IMPLANTED. THIS SUGGEST THAT THERE MAY HAVE BEEN A CONFUSION DURING PLANNING BUT CONSIDERING THAT THE HEAD HOLDER WAS FOUND UNTIGHTENED, A POTENTIAL HEAD SHIFT CANNOT BE RULED OUT. SINCE A NEW REGISTRATION HAS BEEN PERFORMED AS RECOMMENDED IN THE IFU AND NO INACCURACY WAS IDENTIFIED, NO FAILURE RELATED TO THE DEVICE IS SUSPECTED FOR THIS CASE." }, { "mdr_text_key": "322266062", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "THE CLINICAL REPRESENTATIVE REPORTED THAT : 'AFTER THE 4TH ELECTRODE WAS PLACED IN AN SEEG SURGERY, THE ROBOT ARM WAS MOVED TO THE 5TH TRAJECTORY. THE RESIDENT NOTED THAT THE ENTRY POINT WOULD HIT THE PREVIOUSLY PLACED BOLT WHICH DID NOT MATCH THE PLAN. THE TRAJECTORY WAS SKIPPED AND THE ARM WAS MOVED TO THE NEXT TRAJECTORY. THE RESIDENT NOTED THAT THE ARM POINTED TO A SPOT ONE MM AWAY FROM THE MARK MADE PRIOR TO DRAPING. SEVERAL OTHER POINTS WERE CHECKED AND ALL APPEARED TO BE OFF IN DIFFERENT DIRECTIONS AND BETWEEN 1 ¿ 5MM. THE SURGEON DECIDED TO BREAK THE STERILE DRAPES TO TAKE AN INTRAOP CT WITH THE AIRO TO CHECK THE PLACEMENTS. ALL LOCKS WERE CHECKED ON THE ROBOT AND HEAD FRAME AND IT APPEARED THE LEKSELL HEAD FRAME WAS LOOSE AT THE LEKSELL ADAPTOR (THE PIECE THAT CONNECTS THE LEKSELL FRAME TO THE ROSA MAYFIELD ADAPTOR). THE SURGEON WHO FIXATED THE FRAME SAID THAT HE WAS CERTAIN IT WAS NOT LIKE THIS PRIOR TO SURGERY AND THAT HE HAD CONFIRMED IT WAS LOCKED. A SCAN WAS TAKEN AND THE FOUR PLACED ELECTRODES ALIGNED WITH THE PLANNED TRAJECTORIES. THE SURGEON RE-REGISTERED WITH FRAME REGISTRATION. THE POSTOP SCAN SHOWED THE MAJORITY OF THE REMAINING TRAJECTORIES WERE PLACED CORRECTLY. TWO TRAJECTORIES SLIGHTLY DEVIATED/ BENT AND THE SURGEON STATED THIS WAS LIKELY DUE TO NOT PLACING THE STYLET DOWN TO TARGET PRIOR TO PLACING THE ELECTRODE. THE TOTAL DELAY WAS ABOUT 2 HOURS. THERE WAS NO NOTED PATIENT HARM, ASIDE FROM THE ADDITIONAL ANESTHESIA TIME FROM THE DELAY.'" }, { "mdr_text_key": "214146696", "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. UDI# : (B)(4)." }, { "mdr_text_key": "214146697", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THE CLINICAL REPRESENTATIVE REPORTED THAT, \"AFTER THE 4TH ELECTRODE WAS PLACED IN AN SEEG SURGERY, THE ROBOT ARM WAS MOVED TO THE 5TH TRAJECTORY. THE RESIDENT NOTED THAT THE ENTRY POINT WOULD HIT THE PREVIOUSLY PLACED BOLT WHICH DID NOT MATCH THE PLAN. THE TRAJECTORY WAS SKIPPED AND THE ARM WAS MOVED TO THE NEXT TRAJECTORY. THE RESIDENT NOTED THAT THE ARM POINTED TO A SPOT ONE MM AWAY FROM THE MARK MADE PRIOR TO DRAPING. SEVERAL OTHER POINTS WERE CHECKED AND ALL APPEARED TO BE OFF IN DIFFERENT DIRECTIONS AND BETWEEN 1 ¿ 5MM. THE SURGEON DECIDED TO BREAK THE STERILE DRAPES TO TAKE AN INTRAOP CT WITH THE AIRO TO CHECK THE PLACEMENTS. ALL LOCKS WERE CHECKED ON THE ROBOT AND HEAD FRAME, AND IT APPEARED THE LEKSELL HEAD FRAME WAS LOOSE AT THE LEKSELL ADAPTOR (THE PIECE THAT CONNECTS THE LEKSELL FRAME TO THE ROSA MAYFIELD ADAPTOR). THE SURGEON WHO FIXATED THE FRAME SAID THAT HE WAS CERTAIN IT WAS NOT LIKE THIS PRIOR TO SURGERY, AND THAT HE HAD CONFIRMED IT WAS LOCKED. A SCAN WAS TAKEN, AND THE FOUR PLACED ELECTRODES ALIGNED WITH THE PLANNED TRAJECTORIES. THE SURGEON RE-REGISTERED WITH FRAME REGISTRATION. THE POSTOP SCAN SHOWED THE MAJORITY OF THE REMAINING TRAJECTORIES WERE PLACED CORRECTLY. TWO TRAJECTORIES SLIGHTLY DEVIATED/ BENT, AND THE SURGEON STATED THIS WAS LIKELY DUE TO NOT PLACING THE STYLET DOWN TO TARGET PRIOR TO PLACING THE ELECTRODE. THE TOTAL DELAY WAS ABOUT 2 HOURS. THERE WAS NO NOTED PATIENT HARM, ASIDE FROM THE ADDITIONAL ANESTHESIA TIME FROM THE DELAY.\"" } ], "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": "01/29/2021" } ] }