{ "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": "3009185973-2019-00310", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20190906", "manufacturer_address_2": "", "pma_pmn_number": "K151359", "date_of_event": "20190724", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "OTHER", "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": "20190906", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "762980", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20190906", "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 3.0", "catalog_number": "ROSA BRAIN", "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": [ "Imprecision", "Imprecision" ], "reporter_state_code": "OH", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "03/20/2020", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250826", "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": "20190906", "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": "20200325", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "8968608", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20190807", "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": "316703009", "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. THE ANALYSIS OF SOFTWARE LOGS CONCLUDED THAT THE INACCURACY IS CONFIRMED FOR ALL ELECTRODES IMPLANTED WHICH WERE SLIGHTLY DEVIATED IN THE SAME DIRECTION. THE ERROR IS OVER 2 MM FOR ALL ELECTRODES AND IS HOMOGENEOUS. ALTHOUGH THE USER TOOK PRECAUTIONS BY VERIFYING EVERY ENTRY POINTS WITH THE POINTER BEFORE THE IMPLANTATION PROCEDURE, THE MOST PROBABLE CAUSE FOR THE INACCURACY IS A HEAD MOVEMENT. THE ELECTRODES WERE IMPLANTED DEEPER THAN EXPECTED. THIS PARAMETER DEPENDS ON THE METHOD OF IMPLANTATION. THE FUSION BETWEEN PRE-OPERATIVE EXAMS WAS CORRECT. TWO ELECTRODES WERE CURVED AT THE TARGET POINT. THE SHAPE OF THE ELECTRODE ALONG TRAJECTORY DEPENDS ON THE ELECTRODE¿S MATERIAL, THE IMPLANTATION METHOD AND THE PATIENT¿S ANATOMY. CORRECTED DATA: B4 DATE OF THIS REPORT. G4 DATE RECEIVED BY MANUFACTURER. H2 IF FOLLOW-UP, WHAT TYPE. H3 DEVICE EVALUATED BY MANUFACTURER. H6 EVENT PROBLEM AND EVALUATION CODES. H10 ADDITIONAL NARRATIVES/DATA." }, { "mdr_text_key": "316703010", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "THE FIELD SERVICE ENGINEER WAS MADE AWARE OF DEPTH ELECTRODES BEING PLACED INACCURATELY ON (B)(6) 2019. EPILEPSY TEAM MEMBER INFORMED THAT THE 9 OUT 10 ELECTRODES WERE PLACED DEEPER THAN INTENDED BY MARGIN OF AT LEAST 3 OR 4 MM AND IN CERTAIN CASES 9 OR 10MM. HE SHOWED ME THE POST-OPERATIVE CT SCAN AND MERGED IT WITH THE PRE-OP MRI SCAN THAT WAS USED TO PLAN THE ROSA SEEG CASE. NOT ONLY WERE THE ELECTRODES PLACED DEEP BUT THEY WERE ALSO INACCURATE IN TERMS OF BOLT PLACEMENT. THE SURGEON ADJUSTED AND PULLED A FEW OF THE MORE DEEP ELECTRODES BACK FOR BETTER PLACEMENT." }, { "mdr_text_key": "156759958", "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): THE SURGEON ADJUSTED THE ELECTRODES AFTER POST OPERATIVE SCAN. REVISION SURGERY IS CONSIDERED AS SERIOUS INJURY." }, { "mdr_text_key": "156759961", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THE FIELD SERVICE ENGINEER WAS MADE AWARE OF DEPTH ELECTRODES BEING PLACED INACCURATELY ON (B)(6) 2019. EPILEPSY TEAM MEMBER INFORMED THAT THE 9 OUT 10 ELECTRODES WERE PLACED DEEPER THAN INTENDED BY MARGIN OF AT LEAST 3 OR 4 MM AND IN CERTAIN CASES 9 OR 10MM. HE SHOWED ME THE POST-OPERATIVE CT SCAN AND MERGED IT WITH THE PRE-OP MRI SCAN THAT WAS USED TO PLAN THE ROSA SEEG CASE. NOT ONLY WERE THE ELECTRODES PLACED DEEP BUT THEY WERE ALSO INACCURATE IN TERMS OF BOLT PLACEMENT. THE SURGEON ADJUSTED AND PULLED A FEW OF THE MORE DEEP ELECTRODES BACK FOR BETTER PLACEMENT." } ], "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": "03/30/2020" } ] }