{ "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": "MS.", "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": "3009185973-2025-00011", "type_of_report": [ "Initial submission", "Followup", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20250917", "manufacturer_address_2": "", "pma_pmn_number": "K231103", "date_of_event": "20200106", "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": [ "Other", "Consumer", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "574", "date_added": "20250917", "manufacturer_contact_f_name": "JENNIFER", "device_date_of_manufacturer": "20181017", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "14769", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20250917", "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": "N/A", "other_id_number": "", "device_availability": "No", "device_report_product_code": "HAW", "device_age_text": "DAY", "device_evaluated_by_manufacturer": "N", "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": [ "Positioning Problem", "Activation, Positioning or Separation Problem", "Positioning Problem" ], "reporter_state_code": "FL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "11/26/2025;03/24/2026;06/05/2026", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20260608", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "5745", "patient": [ { "patient_sequence_number": "1", "date_received": "20250917", "sequence_number_treatment": [ "NEUROPACE, INCMODEL: RNS-320-KSERIAL: (B)(6)" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "40 YR", "patient_sex": "Male", "patient_weight": "70 KG", "patient_ethnicity": "", "patient_race": "White", "patient_problems": [ "Headache", "Memory Loss/Impairment", "Pain", "Scar Tissue", "Anxiety", "Convulsion/Seizure", "Eye Pain", "Headache", "Memory Loss/Impairment", "Pain", "Scar Tissue", "Anxiety", "Convulsion/Seizure", "Eye Pain" ] } ], "distributor_city": "", "date_report": "20260605", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "WARSAW", "mdr_report_key": "23072991", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20250902", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "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": "380281675", "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 IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED." }, { "mdr_text_key": "380281676", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED DURING A ROSA BRAIN PROCEDURE, AN RNS NEUROSTIMULATOR KIT (COMPETITOR PRODUCT) WAS PLACED INTO THE WRONG SPOT IN THE OPTICAL NERVE. THE PATIENT HAS EXPERIENCED PAIN SINCE THE PROCEDURE. DURING FOLLOW-UP EVALUATION, THE FREQUENCY WAS INCREASED ON THE RNS DEVICE WHICH CAUSED A SEIZURE. IT WAS CONFIRMED AT THAT TIME THAT THE RNS WAS PLACED IN THE WRONG LOCATION. THE DEVICE WAS REMOVED AND REPLACED APPROXIMATELY 4 (FOUR) YEARS LATER. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME." }, { "mdr_text_key": "400867675", "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: D4; H2; H4 H6; H11 THE REPORTED EVENT COULD NOT BE CONFIRMED DUE TO LACK OF INFORMATION. THE ROSA LOG FILES FOR THE EVENT WERE NOT AVAILABLE FOR ANALYSIS; AS SUCH FURTHER REVIEW OF THE SOFTWARE PERFORMANCE DURING THE EVENT COULD NOT BE PERFORMED. NO INFORMATION WAS PROVIDED TO CONFIRM A ROSA DEVICE MALFUNCTION. 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." }, { "mdr_text_key": "400867676", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT." }, { "mdr_text_key": "15617173118", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A BRAIN PROCEDURE UTILIZING A ROBOTIC SURGICAL SYSTEM, A NEUROSTIMULATOR SYSTEM WAS PLACED IN THE WRONG LOCATION, AND THE DEVICE WAS SUBSEQUENTLY REMOVED AND REPLACED APPROXIMATELY FOUR YEARS LATER.AFTER THE INITIAL IMPLANTATION, THE PATIENT EXPERIENCED EYE AND FACIAL PAIN, ISSUES WITH THE LEFT EYE, MEMORY DIFFICULTIES, MORE INTENSE AND MORE FREQUENT SEIZURES, FREQUENT MIGRAINE HEADACHES, AND ANXIETY. DURING A FOLLOW-UP EVALUATION, STIMULATION FREQUENCY WAS INCREASED ON THE NEUROSTIMULATOR, WHICH PRECIPITATED A SEIZURE. AT THAT TIME, MALPOSITION OF THE NEUROSTIMULATOR SYSTEM WAS CONFIRMED. THE PATIENT ALSO REPORTED PERCEIVING STIMULATION OVER THE LEFT TEMPLE WHERE A LEAD WAS PLACED, WITH SENSATIONS WORSENING AS STIMULATION PARAMETERS WERE INCREASED.ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED." }, { "mdr_text_key": "16117173119", "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: B3; B5; B7; D2; G3; H6.THE REPORTED EVENT COULD NOT BE CONFIRMED DUE TO LACK OF INFORMATION.HOWEVER, THE POST-OPERATIVE EXAMS WERE NOT PROVIDED THUS, THE ALLEGED ELECTRODE INACCURACY COULD NOT BE CONFIRMED.A FULL ANALYSIS OF THE DATA LOGS FROM THE INITIAL SURGERY ON (b)(6) 2020 WAS PERFORMED. A REVIEW OF ROSA LOGS DID NOT IDENTIFY ANY SOFTWARE ANOMALIES WHICH MAY HAVE CONTRIBUTED TO THE EVENT. THERE WERE NO FATAL ERRORS OBSERVED AND THE USER FOLLOWED PROPER WORKFLOW. AUTOMATIC REGISTRATION WAS PERFORMED WITH OPTICAL DISTANCE SENSOR (S/N: (b)(6)). THE REGISTRATION RMS WAS WITHIN ACCEPTABLE SYSTEMS. NO ISSUES WERE OBSERVED WITH THE REGISTRATION VERIFICATION; ALL POINTS WERE WITHIN THE SYSTEM¿S 2 MM THRESHOLD. REVIEW OF THE VERIFICATION SCREENSHOTS FOUND NO ISSUE WITH THE ACCURACY VERIFICATION PROCEDURE. ALL POINTS WERE TAKEN AT THE RECOMMENDED ANATOMICAL POINT.NO ISSUES WERE OBSERVED IN THE DEVICE INTERVENTIONS PRIOR TO AND AFTER THE REPORTED EVENT.NO INFORMATION WAS PROVIDED TO CONFIRM A ROSA DEVICE MALFUNCTION.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." }, { "mdr_text_key": "394702556", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED DURING A ROSA BRAIN PROCEDURE, AN RNS NEUROSTIMULATOR KIT (COMPETITOR PRODUCT) WAS PLACED INTO THE WRONG SPOT IN THE OPTICAL NERVE. THE PATIENT HAS EXPERIENCED EYE AND FACIAL PAIN SINCE THE PROCEDURE. THE PATIENT HAS REPORTED ISSUES WITH THE LEFT EYE AND EXTREME MEMORY ISSUES ALONG WITH MORE INTENSE AND MORE FREQUENT SEIZURES AS WELL AS FREQUENT MIGRAINE HEADACHES FROM ALL THE INCISIONS AND SCAR TISSUE AND EXTREME ANXIETY. DURING FOLLOW-UP EVALUATION, THE FREQUENCY WAS INCREASED ON THE RNS DEVICE WHICH CAUSED A SEIZURE. IT WAS CONFIRMED AT THAT TIME THAT THE RNS WAS PLACED IN THE WRONG LOCATION. THE DEVICE WAS REMOVED AND REPLACED APPROXIMATELY 4 (FOUR) YEARS LATER. NO FURTHER INFORMATION AVAILABLE." }, { "mdr_text_key": "394702557", "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/CORRECTED UPDATED: A2, A6, B4, B5, B7, G3, H2, H6." } ], "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": "574", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "12/16/2025;03/31/2026;06/08/2026" } ] }