{ "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": "", "report_to_fda": "N", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "IN", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "MAUGUIO, LANGUEDOC-ROUSSILLON", "manufacturer_contact_address_1": "56 E. BELL DRIVE", "manufacturer_contact_pcity": "57452603", "event_type": "Injury", "report_number": "3009185973-2026-00001", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20260210", "manufacturer_address_2": "", "pma_pmn_number": "K231103", "date_of_event": "20260113", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "46582", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "5745260384", "noe_summarized": "1", "manufacturer_contact_l_name": "RAPSAVAGE", "source_type": [ "Health Professional", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "34130", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20260210", "manufacturer_contact_f_name": "JENNIFER", "device_date_of_manufacturer": "20230712", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "363813", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20260210", "brand_name": "ROSA ONE BRAIN", "generic_name": "NEUROLOGICAL STEREOTAXIC INSTRUMENT", "manufacturer_d_name": "MEDTECH SAS", "manufacturer_d_address_1": "432 RUE DU RAJOL", "manufacturer_d_address_2": "", "manufacturer_d_city": "MAUGUIO, LANGUEDOC-ROUSSILLON", "manufacturer_d_state": "", "manufacturer_d_zip_code": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "ROSAS00203", "lot_number": "3.1.6.432", "other_id_number": "", "device_availability": "No", "device_report_product_code": "HAW", "device_age_text": "DAY", "device_evaluated_by_manufacturer": "Y", "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", "Positioning Problem" ], "reporter_state_code": "OH", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "06/11/2026", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20260901", "health_professional": "Y", "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": "20260210", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Intracranial Hemorrhage" ] } ], "distributor_city": "", "date_report": "20260611", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "WARSAW", "mdr_report_key": "24305807", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20260113", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "34130", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "MEDTECH SAS", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "N", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "392594813", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "(B)(4). THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED." }, { "mdr_text_key": "392594814", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT FOLLOWING A SEEG PROCEDURE, THE PATIENT DEVELOPED A HEMATOMA DUE TO INACCURATE ELECTRODE PLACEMENT. THE TEAM COMPLETED LASER REGISTRATION AND REPORTED GOOD ACCURACY DURING THE VERIFICATION STEP. THEY COMPLETED A POST-OP CT SCAN AND NOTICED THAT SEVERAL OF THE ENTRIES WERE 5+MM OFF FROM THE PLAN. THE SURGEON REPORTS THAT SEVERAL OF THE ELECTRODES ARE DEFLECTED IN THE BRAIN, BUT THIS IS DUE TO THE PATIENT¿S TUBEROUS SCLEROSIS. THE SURGEON¿S PRIMARY CONCERN IS THE INACCURACIES AT THE ENTRY POINTS. THE PATIENT IS STABLE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME." }, { "mdr_text_key": "15630036708", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INTRACRANIAL HEMATOMA FOLLOWING A STEREOELECTROENCEPHALOGRAPHY PROCEDURE ASSOCIATED WITH INACCURATE ELECTRODE PLACEMENT. DURING THE CASE, THE TEAM COMPLETED LASER REGISTRATION AND REPORTED GOOD ACCURACY DURING VERIFICATION. A POSTOPERATIVE CT SCAN SUBSEQUENTLY SHOWED SEVERAL ENTRY POINTS WERE APPROXIMATELY MORE THAN 5 MM FROM THE PLANNED TRAJECTORIES. THE SURGEON NOTED SEVERAL ELECTRODES APPEARED DEFLECTED WITHIN THE BRAIN, ATTRIBUTED TO THE PATIENT¿S TUBEROUS SCLEROSIS, WITH PRIMARY CONCERN FOR INACCURACIES AT THE ENTRY POINTS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED." }, { "mdr_text_key": "16130036711", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.THE FOLLOWING SECTIONS WERE UPDATED: A1; B5; B6; B7; D2; D4; D9; E1; G3; H3; H4; H6.THE REPORTED EVENT WAS CONFIRMED BY REVIEW OF POST-OP CT-BONE EXAM.TECHNICAL REVIEW AND PHYSICAL EVALUATION: THE REPORTED ELECTRODE PLACEMENT INACCURACIES AT THE ENTRY POINT WERE CONFIRMED BY REVIEW OF THE PROVIDED POST-OP CT-BONE EXAM, WITH DEVIATIONS OF >2MM SEEN ON THE RIGHT SIDE OF THE PATIENT. THERE WAS A SIMILAR SHIFT IN THE ELECTRODES WHICH CAN INDICATE HEAD/ HEAD HOLDER MOVEMENT. AS REPORTED IN THE COMPLAINT DESCRIPTION, THE DEVIATION IN TARGET POINTS WAS DUE TO A PREEXISTING CONDITION.THE DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND.A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED.IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "432 RUE DU RAJOL", "distributor_zip_code": "", "manufacturer_contact_postal_code": "46582", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "06/12/2026" } ] }