{ "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": "3009185973-2020-00187", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20200731", "manufacturer_address_2": "", "pma_pmn_number": "K182417", "date_of_event": "20200722", "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": "20200731", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "813329", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "N", "date_received": "20200731", "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": [ "Malposition of Device", "Malposition of Device" ], "reporter_state_code": "AL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "06/30/2021", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250818", "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": "20200731", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Code Available", "No Clinical Signs, Symptoms or Conditions", "No Code Available", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20210630", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10348747", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20200723", "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": "325469587", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "DHR REVIEW AND REVIEW OF COMPLAINT HISTORY DID NOT IDENTIFY ANY CONTRIBUTORY FACTORS TO THE EVENT. ALTHOUGH TWO INITIAL POINTS WERE NOT COLLECTED PROPERLY, THE REGISTRATION WAS ACCURATE REGARDING THE SPECIFICATION LIMITS. THE RESULT OF VERIFICATION WAS NOT CORRECT ON ALL POINTS BUT THE VALIDATION IS AT THE USER¿S CHARGE. THE REVIEW OF THE IFU SHOWS THAT IF IMAGE POINTS ARE RE-POSITIONED, THEY HAVE TO BE RE-COLLECTED WITH THE ROBOT. MULTIPLE EXAMS WERE MISSING AND MULTIPLE INCONSISTENCE WERE FOUND IN THE PATIENT FOLDER. THE FUSION OF PRE-OPERATIVE EXAMS COULD NOT BE CHECKED SINCE THEIR IDENTIFICATION WAS COMPROMISED. THE CT POST-OPERATIVE OF THE CASE WAS NOT PROVIDED. THEREFORE, THE INACCURACY REPORTED CANNOT BE CONFIRMED. CORRECTED DATA: - B4 DATE OF THIS REPORT. - 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": "325469588", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "ON (B)(6) 2020, THE SURGEON NOTIFIED THE CLINICAL REPRESENTATIVE (CR) WHO ASSISTED THE SURGERY, THAT DURING THE POST OP SCAN AND MERGE THERE WAS DEVIATION FROM THE PLANNED ENTRY BY ~5MM. THE SURGEON SAID THERE WAS NO IMPACT TO THE PATIENT, BUT THE READING ON THE RNS DEPTH LEADS WILL BE AFFECTED AS THEY ARE NOT IN THE PLANNED LOCATION. THE PATIENT WAS REGISTERED USING CONTACTLESS REGISTRATION. THE PATIENT WAS WEARING A FACE MASK DURING THE CT SCAN, SO THE METAL BRIDGE OF THE FACE MASK AS WELL AS THE ELASTIC LOOPS OF THE MASK WERE PROMINENT IN THE SCAN. THE VERIFICATION PROCESS LOOKED TO BE WITHIN ACCEPTABLE RANGE AND NO NOTICEABLE SHIFTS IN THE HEAD OCCURRED TO THE CR¿S AND SURGEON¿S KNOWLEDGE." }, { "mdr_text_key": "202341488", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE DIAGNOSIS OF THE PATIENT MAY NOT BE POSSIBLE DUE TO THE INACCURATE PLACEMENT OF THE LEADS THAT WAS PERFORMED WITH ROSA ONE DEVICE. (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": "202341489", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ON (B)(6) 2020, THE SURGEON NOTIFIED THE FIELD SERVICE ENGINEER (FSE) WHO ASSISTED THE SURGERY, THAT DURING THE POST OP SCAN AND MERGE THERE WAS DEVIATION FROM THE PLANNED ENTRY BY ~5MM. THE SURGEON SAID THERE WAS NO IMPACT TO THE PATIENT, BUT THE READING ON THE RNS DEPTH LEADS WILL BE AFFECTED AS THEY ARE NOT IN THE PLANNED LOCATION. THE PATIENT WAS REGISTERED USING CONTACTLESS REGISTRATION. THE PATIENT WAS WEARING A FACE MASK DURING THE CT SCAN, SO THE METAL BRIDGE OF THE FACE MASK AS WELL AS THE ELASTIC LOOPS OF THE MASK WERE PROMINENT IN THE SCAN. THE VERIFICATION PROCESS LOOKED TO BE WITHIN ACCEPTABLE RANGE AND NO NOTICEABLE SHIFTS IN THE HEAD OCCURRED TO THE FSE¿S AND SURGEON¿S KNOWLEDGE." } ], "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": "07/07/2021" } ] }