{ "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": "3009185973-2019-00008", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20190111", "manufacturer_address_2": "", "pma_pmn_number": "K172444", "date_of_event": "20181121", "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": "20190111", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "31754", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20190111", "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": [ "Appropriate Device Problem Term/Code Not Available", "Appropriate Device Problem Term/Code Not Available" ], "reporter_state_code": "CA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/31/2019;01/20/2020", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250805", "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": "20190111", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hemorrhage, Cerebral", "Hemorrhage, Cerebral" ] } ], "distributor_city": "", "date_report": "20200120", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "8239434", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20181217", "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": "312104966", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS REPORT CORRECTS THE UDI NUMBER PROVIDED IN SECTION H10 OF THE INITIAL REPORT. UDI# : (B)(4)." }, { "mdr_text_key": "312104967", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "WHILE TALKING TO THE ELECTROPHYSIOLOGY GROUP, THEY RELAYED AN EVENT THAT OCCURRED TO THE PATIENT FROM (B)(6) 2018. THEY STATED THAT THE PATIENT HAD A BLEED DUE TO AN ELECTRODE DEVIATING INSIDE OF THE SKULL AND ANOTHER ELECTRODE TEARING DURING THE REMOVAL PROCESS. THE RESIDENT TOLD TO THE FIELD SERVICE ENGINEER (FSE) THE FOLLOWING: - A SMALL EPIDURAL HEMATOMA OCCURRED POST-OPERATIVELY - CAUSE THOUGHT TO BE A DURAL PUNCTURE DUE TO DRILLING - IT WAS DETERMINED ON POST-OP THAT THE ELECTRODE (RSB) RELATED TO THE BLEED DEVIATED AND WAS EPIDURAL - THE PATIENT EXPERIENCED SOME TRANSIENT WEAKNESS ON THE LEFT SIDE (CONTRALATERAL TO RSB) BUT THE WEAKNESS RESOLVED BEFORE THE ELECTRODE WAS REMOVED - THE SEIZURE FOCUS WAS SUCCESSFULLY MAPPED AND THE EPILEPSY GROUP IS CURRENTLY DETERMINING NEXT STEPS FOR THE PATIENT. - THE RESIDENT ALSO MENTIONED THAT IT WAS DISCOVERED DURING REMOVAL THAT ONE ELECTRODE HAD BEEN TORN OR CUT AND THAT A CRANIOTOMY WAS NECESSARY TO FULLY REMOVE THE ELECTRODE FROM THE PATIENT. HE BELIEVES THAT THIS WAS DUE TO THE FACT THAT THE BROKEN ELECTRODE WAS CLOSE TO ANOTHER ELECTRODE AT IMPLANT AND THAT THE BROKEN ELECTRODE MAY HAVE BEEN CAUSED WHEN THE SECOND ELECTRODE WAS DRILLED AND THE DRILL BIT CUT THE ELECTRODE THAT WAS ALREADY IMPLANTED. - THE PATIENT EXPERIENCED NO LONG TERM INJURY THE FSE WHO REPORTED THIS EVENT SPOKE WITH THE FSE PRESENT FOR THE CASE AND HE CONFIRMED THAT PRIOR TO EACH IMPLANT HE INFORMED THE SURGEON OF THE SKULL THICKNESS AND THAT THERE WAS NO AWARENESS OF THE BLEED WHILE HE WAS ON SITE FOR THE SURGERY." }, { "mdr_text_key": "132778213", "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": "132778214", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "WHILE TALKING TO THE ELECTROPHYSIOLOGY GROUP, THEY RELAYED AN EVENT THAT OCCURRED TO THE PATIENT FROM (B)(6) 2018. THEY STATED THAT THE PATIENT HAD A BLEED DUE TO AN ELECTRODE DEVIATING INSIDE OF THE SKULL AND ANOTHER ELECTRODE TEARING DURING THE REMOVAL PROCESS. THE RESIDENT TOLD TO THE FIELD SERVICE ENGINEER (FSE) THE FOLLOWING: A SMALL EPIDURAL HEMATOMA OCCURRED POST-OPERATIVELY. CAUSE THOUGHT TO BE A DURAL PUNCTURE DUE TO DRILLING. IT WAS DETERMINED ON POST-OP THAT THE ELECTRODE (RSB) RELATED TO THE BLEED DEVIATED AND WAS EPIDURAL. THE PATIENT EXPERIENCED SOME TRANSIENT WEAKNESS ON THE LEFT SIDE (CONTRALATERAL TO RSB) BUT THE WEAKNESS RESOLVED BEFORE THE ELECTRODE WAS REMOVED. THE SEIZURE FOCUS WAS SUCCESSFULLY MAPPED AND THE EPILEPSY GROUP IS CURRENTLY DETERMINING NEXT STEPS FOR THE PATIENT. THE RESIDENT ALSO MENTIONED THAT IT WAS DISCOVERED DURING REMOVAL THAT ONE ELECTRODE HAD BEEN TORN OR CUT AND THAT A CRANIOTOMY WAS NECESSARY TO FULLY REMOVE THE ELECTRODE FROM THE PATIENT. HE BELIEVES THAT THIS WAS DUE TO THE FACT THAT THE BROKEN ELECTRODE WAS CLOSE TO ANOTHER ELECTRODE AT IMPLANT AND THAT THE BROKEN ELECTRODE MAY HAVE BEEN CAUSED WHEN THE SECOND ELECTRODE WAS DRILLED AND THE DRILL BIT CUT THE ELECTRODE THAT WAS ALREADY IMPLANTED. THE PATIENT EXPERIENCED NO LONG TERM INJURY. THE FSE WHO REPORTED THIS EVENT SPOKE WITH THE FSE PRESENT FOR THE CASE AND HE CONFIRMED THAT PRIOR TO EACH IMPLANT HE INFORMED THE SURGEON OF THE SKULL THICKNESS AND THAT THERE WAS NO AWARENESS OF THE BLEED WHILE HE WAS ON SITE FOR THE SURGERY." }, { "mdr_text_key": "318037147", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT POST-OPERATIVELY, IT WAS FOUND THAT THE PATIENT HAD AN EPIDURAL HEMATOMA BECAUSE OF A DEVIATED ELECTRODE AND THAT ONE ELECTRODE WAS BROKEN DURING REMOVAL. DHR REVIEW AND REVIEW OF COMPLAINT HISTORY DID NOT IDENTIFY ANY CONTRIBUTORY FACTORS TO THE EVENT. ACCORDING TO TECHNICAL INVESTIGATION 15 TRAJECTORIES AMONG 20 PLANNED WERE FOUND TO BE IMPLANTED INACCURATELY AT THE ENTRY POINT (OVER 2MM AWAY). THE INACCURACY MIGHT HAVE PLAYED A ROLE IN THE ISSUES ENCOUNTERED ON THESE TRAJECTORIES. THE PATIENT¿S RESPONSE TO PUNCTURE ON DURA ALSO DEPENDS ON THE PATIENT¿S MORPHOLOGY. GLOBALLY, THE INACCURATE ELECTRODES WERE IMPLANTED IN THE FRONTAL AND PARIETAL LOBES. THE DEVIATION ANALYSIS SUGGESTS THAT AN INELASTIC MOVEMENT OF THE HEAD MAY HAVE OCCURRED DURING THE SURGERY OR THAT THE REGISTRATION WAS VALIDATED WITH THIS ROTATION. THE REGISTRATION WAS CORRECTLY EXECUTED BUT AS THE USER CHOSE NOT TO CHECK THE PATIENT¿S LEFT SIDE DURING THE VERIFICATION STEP, IT IS NOT POSSIBLE TO DETERMINE THE CAUSE FOR THE OBSERVED DEVIATIONS. 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." }, { "mdr_text_key": "318037148", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "WHILE TALKING TO THE ELECTROPHYSIOLOGY GROUP, THEY RELAYED AN EVENT THAT OCCURRED TO THE PATIENT FROM (B)(6)2018 . THEY STATED THAT THE PATIENT HAD A BLEED DUE TO AN ELECTRODE DEVIATING INSIDE OF THE SKULL AND ANOTHER ELECTRODE TEARING DURING THE REMOVAL PROCESS. THE RESIDENT TOLD TO THE FIELD SERVICE ENGINEER (FSE) THE FOLLOWING: - A SMALL EPIDURAL HEMATOMA OCCURRED POST-OPERATIVELY - CAUSE THOUGHT TO BE A DURAL PUNCTURE DUE TO DRILLING - IT WAS DETERMINED ON POST-OP THAT THE ELECTRODE (RSB) RELATED TO THE BLEED DEVIATED AND WAS EPIDURAL - THE PATIENT EXPERIENCED SOME TRANSIENT WEAKNESS ON THE LEFT SIDE (CONTRALATERAL TO RSB) BUT THE WEAKNESS RESOLVED BEFORE THE ELECTRODE WAS REMOVED - THE SEIZURE FOCUS WAS SUCCESSFULLY MAPPED AND THE EPILEPSY GROUP IS CURRENTLY DETERMINING NEXT STEPS FOR THE PATIENT. - THE RESIDENT ALSO MENTIONED THAT IT WAS DISCOVERED DURING REMOVAL THAT ONE ELECTRODE HAD BEEN TORN OR CUT AND THAT A CRANIOTOMY WAS NECESSARY TO FULLY REMOVE THE ELECTRODE FROM THE PATIENT. HE BELIEVES THAT THIS WAS DUE TO THE FACT THAT THE BROKEN ELECTRODE WAS CLOSE TO ANOTHER ELECTRODE AT IMPLANT AND THAT THE BROKEN ELECTRODE MAY HAVE BEEN CAUSED WHEN THE SECOND ELECTRODE WAS DRILLED AND THE DRILL BIT CUT THE ELECTRODE THAT WAS ALREADY IMPLANTED. - THE PATIENT EXPERIENCED NO LONG TERM INJURY THE FSE WHO REPORTED THIS EVENT SPOKE WITH THE FSE PRESENT FOR THE CASE AND HE CONFIRMED THAT PRIOR TO EACH IMPLANT HE INFORMED THE SURGEON OF THE SKULL THICKNESS AND THAT THERE WAS NO AWARENESS OF THE BLEED WHILE HE WAS ON SITE FOR THE SURGERY." } ], "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": "08/27/2019;01/29/2020" } ] }