{ "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": "MR.", "manufacturer_contact_state": "FL", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "MAUGUIO, LANGUEDOC-ROUSSILLON", "manufacturer_contact_address_1": "1520 TRADEPORT DRIVE", "manufacturer_contact_pcity": "90474144", "event_type": "Injury", "report_number": "3009185973-2024-00017", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20241112", "manufacturer_address_2": "", "pma_pmn_number": "K214065", "date_of_event": "20240819", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "32218", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "9047414400", "noe_summarized": "1", "manufacturer_contact_l_name": "SHARMA", "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": "904", "date_added": "20241112", "manufacturer_contact_f_name": "JAY", "device_date_of_manufacturer": "20230720", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "976308", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "U", "date_received": "20241112", "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": "N/A", "catalog_number": "ROSAS00203", "lot_number": "3.1.6.432", "other_id_number": "", "device_availability": "Yes", "device_report_product_code": "HAW", "device_age_text": "DA", "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": [ "Incorrect, Inadequate or Imprecise Result or Readings", "Incorrect, Inadequate or Imprecise Result or Readings" ], "reporter_state_code": "MI", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "02/13/2025;07/23/2025", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20251003", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "9047", "patient": [ { "patient_sequence_number": "1", "date_received": "20241112", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "13 YR", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding", "Hemorrhage/Blood Loss/Bleeding" ] } ], "distributor_city": "", "date_report": "20250723", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "FR", "manufacturer_contact_city": "JACKSONVILLE", "mdr_report_key": "20662827", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20240819", "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": "356431155", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT THE PATIENT HAD A BRAIN BLEED FOLLOWING SEEG CASE. ALL TRAJECTORIES WERE OFF BY 2-3MM. DURING THE CASE, LASER REGISTRATION WAS PREFORMED AND VERIFICATION LOOKED GOOD. SICK BOX HAS BEEN CHECKED FOR CORRECT PARAMETERS BEFORE EVERY CASE. NO FURTHER INFORMATION KNOWN." }, { "mdr_text_key": "356431156", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "CMP (B)(4) H3: CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE WHOLE SYSTEM DOES NOT GET RETURNED FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED." }, { "mdr_text_key": "364438715", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "(B)(4). RESULTS OF THE LOG FILE INVESTIGATION CONFIRMED ELECTRODE ENTRY DISCREPANCIES >2MM FOR ALL ELECTRODES. THE FOLLOWING FACTS WERE IDENTIFIED IN THE LOGS: ¿ FUSION: THERE WERE NO ISSUES FOUND WITH THE EXAMS PROVIDED. THE MERGED PRE-OP MRI AND CT EXAMS APPEARED FINE. THE FUSION BETWEEN PRE-OPERATIVE POST-OPERATIVE CT EXAMS DID SHOW A SHIFT OF THE HEAD. ¿ REGISTRATION: AUTOMATIC LASER REGISTRATION WAS PERFORMED AND RESULTING IN AN RMS WITHIN THE THRESHOLD. ¿ VERIFICATION: THE REGISTRATION VERIFICATION DISTANCE ERRORS FOR ALL VERIFICATION POINTS WERE WITHIN THE SYSTEM¿S THRESHOLD. THE REGISTRATION VERIFICATION SCREENSHOTS WERE REVIEWED, AND ALL POINTS WERE TAKEN IN THE RECOMMENDED ANATOMICAL LOCATIONS AS INDICATED BY THE SYSTEM. ¿ ELECTRODE DEVIATION - ENTRY POINT: THE AVERAGE DEVIATION FOR ENTRY POINTS FOR ALL ELECTRODES WERE GREATER THAN SYSTEM¿S SPECIFICATION. A REVIEW OF THE PLANNED VS ACTUAL ELECTRODE PLACEMENT DID SHOW ALL ENTRY POINTS WERE SHIFTED IN THE SAME DIRECTIONAL, WHICH CAN INDICATE HEAD MOVEMENT. BASED ON THE PRE- AND POST-OP CT FUSION AND THE PLANNED VS ACTUAL ELECTRODE PLACEMENT, THE MOST LIKELY CAUSE OF THE DISCREPANCY SEEN WOULD BE A HEAD SHIFT. THERE WERE NO SOFTWARE ANOMALIES IDENTIFIED WHICH CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. THE ELECTRODE INACCURACIES WERE CONFIRMED, BUT THE DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THERE IS NO EVIDENCE TO INDICATE THAT THE ROSA MALFUNCTIONED OR CONTRIBUTED TO THE ADVERSE EVENT. THE CAUSE OF THE BLEEDING CANNOT BE DETERMINED WITH THE INFORMATION AVAILABLE. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS." }, { "mdr_text_key": "364438716", "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": "380413951", "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 (UPDATE/CORRECTED). CORRECTED: G4. UPDATED: G3; H2." }, { "mdr_text_key": "380413952", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "432 RUE DU RAJOL", "distributor_zip_code": "", "manufacturer_contact_postal_code": "32218", "manufacturer_contact_exchange": "904", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "02/14/2025;07/23/2025" } ] }