{ "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": "3009185973-2024-00016", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20241111", "manufacturer_address_2": "", "pma_pmn_number": "K214065", "date_of_event": "20241021", "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": "574", "date_added": "20241111", "manufacturer_contact_f_name": "JENNIFER", "device_date_of_manufacturer": "20230720", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "975241", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "U", "date_received": "20241111", "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": "N/A", "other_id_number": "", "device_availability": "Yes", "device_report_product_code": "HAW", "device_age_text": "DA", "device_evaluated_by_manufacturer": "N", "combination_product_flag": "N", "udi_di": "03760244030948", "udi_public": "(01)03760244030948", "openfda": { "device_name": "Neurological Stereotaxic Instrument", "medical_specialty_description": "Neurology", "regulation_number": "882.4560", "device_class": "2" } } ], "product_problems": [ "Incorrect Measurement", "Incorrect Measurement" ], "reporter_state_code": "TN", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "03/11/2025;07/23/2025", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20250918", "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": "20241111", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "NA", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Clinical Signs, Symptoms or Conditions", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20250723", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "FR", "manufacturer_contact_city": "WARSAW", "mdr_report_key": "20658051", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20241021", "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": "366904572", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. D4: FULL DEVICE UDI- (B)(4). H4: DEVICE MANUFACTURING DATE OF MAY 13, 2019, MANUFACTURING DATE IN H4 REFLECTS LATEST DEVICE SOFTWARE UPDATE DATE. TECHNICAL REVIEW AND PHYSICAL EVALUATION: A FULL ANALYSIS OF THE DATA LOGS WAS PERFORMED. THE LOGS CONFIRMED ELECTRODE INACCURACY AT THE ENTRY POINT AND TARGET POINT FOR ONE OF THE ELECTRODES. THE AVERAGE ERROR WAS GREATER THAN THE SYSTEM LIMIT, HOWEVER IT WAS LESS THAN THE 10MM REPORTED BY THE USER. A REVIEW OF ROSA LOGS DID NOT IDENTIFY ANY SOFTWARE ANOMALIES WHICH MAY HAVE CONTRIBUTED TO THE EVENT. THE ENTRY AND TARGET POINTS WERE REVIEWED WITH THE ROSA SOFTWARE AND IT DID REVEAL THE PLANNED PLACEMENT FOR EACH ELECTRODE WAS MORE POSTERIOR THAN THE ACTUAL PLACEMENT. USER ERROR WAS IDENTIFIED DURING REGISTRATION VERIFICATION. THE USER SKIPPED THE LAST VERIFICATION AND CHOSE TO VALIDATE THE HIGH ERRORS AT EACH VERIFICATION POINT, WHICH IS NOT ADVISED AND CAN CONTRIBUTE TO INACCURACIES. THE COMPLAINT DESCRIPTION DID CONFIRM THE USER INPUTTED INCORRECT COORDINATES FOR THE ORIGIN POINT DURING PLANNING. THE ACPC MENU PROVIDES THE TOOLS TO DEFINE THE ACPC COORDINATES. THE DEFINITION OF THESE LANDMARKS ALLOWS FOR IMAGE CORRECTION AND THE DEFINITION OF ANY OTHER POINTS USING THESE COORDINATES. THE USER CHOSE PC INSTEAD OF THE ¿/2¿ WHICH IS BETWEEN AC AND PC. THIS WOULD EXPLAIN THE PLANNED TRAJECTORIES APPEARING MORE POSTERIOR THAN THE ACTUAL ELECTRODE. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELATED TO THE REPORTED EVENT WERE FOUND. THE DEFINITIVE ROOT CAUSE WAS DETERMINED TO BE USER ERROR DURING PLANNING. GUIDANCE ON NAVIGATING THE ACPC MENU IS PROVIDED IN THE ROSA ONE BRAIN APPLICATION QUICK REFERENCE GUIDE AND WITHIN SECTION (ACPC) IN THE USER MANUAL. THE ROSA ONE BRAIN APPLICATION USER MANUAL ALSO PROVIDES INFORMATION ON THE METHODS FOR REGISTRATION AND WARNS USER THAT REGISTRATION ERROR CAN CAUSE INACCURACIES IN SECTION REGISTRATION METHODS. SECTION REGISTRATION DETAILS THE PROCEDURE TO PERFORM A REGISTRATION AND VERIFICATION. A SUMMARY OF THE INVESTIGATION WAS SENT TO THE COMPLAINANT CONVEYING PROPER SURGICAL TECHNIQUE AND USE OF THE DEVICE. 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": "366904573", "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": "380414088", "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": "380414089", "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": "356423241", "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 ROBOT IS NOT RETURNED FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED." }, { "mdr_text_key": "356423242", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT THE SURGEON REPORTED AN ANTERIOR ERROR OF DBS LEAD PLACEMENT APPROXIMATELY 10 MM FROM INTENDED TARGET (GPI). POST-OP SCANS WERE LOADED INTO NON-ROSA SOFTWARE, LEADING TO THE DISCOVERY OF THE ERROR. REVISION SURGERY NEEDED TO CORRECT ERROR AND REPLACE BOTH LEADS. THE CST EVALUATED THE ROSA PLAN FOLLOWING THE PROCEDURE AND DETERMINED THAT THE ERROR RESULTED FROM INCORRECT TARGET POINT AC/PC COORDINATES. SURGEON INPUTTED COORDINATES WITH THE INTENDED ORIGIN BEING THE MIDPOINT BETWEEN AC/PC. HOWEVER, THE ORIGIN SELECTED ON THE ROSA SOFTWARE WAS PC, RESULTING IN INACCURATE PLANNING AND THEREFORE INACCURATE LEAD PLACEMENT. ATTEMPTS HAVE BEEN MADE AND THERE IS NO FURTHER INFORMATION AT THIS TIME." } ], "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": "03/26/2025;07/23/2025" } ] }