{ "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": "3009185973-2024-00003", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20240301", "manufacturer_address_2": "", "pma_pmn_number": "K214065", "date_of_event": "20240202", "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": "20240301", "manufacturer_contact_f_name": "JAY", "device_date_of_manufacturer": "20221220", "previous_use_code": "U", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "306883", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "U", "date_received": "20240301", "brand_name": "ROSA ONE BRAIN", "generic_name": "MULTI-PURPOSE STEREOTACTIC SURGERY SYSTEM", "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": "3.1.6.276", "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": "AZ", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/29/2024;07/22/2025", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20251014", "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": "20240301", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization" ], "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": "20250722", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "FR", "manufacturer_contact_city": "JACKSONVILLE", "mdr_report_key": "18816748", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20240202", "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": "336664477", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "(B)(4). THE DEVICE HAS NOT BEEN EVALUATED YET FOR INVESTIGATION PURPOSE. ONCE THE EVALUATION IS PERFORMED AND THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED." }, { "mdr_text_key": "336664482", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "THE SURGEON WAS CHECKING THE FIRST TRAJECTORY OF A BILATERAL ANTERIOR NUCLEUS OF THE THALAMUS DEEP BRAIN STIMULATION CASE. THE TRAJECTORY DEVIATED FROM THE PLAN BY AT LEAST 2.5MM, SLIGHTLY MORE DEVIATED AT THE TARGET THAN THE ENTRY POINT. THE SURGEON CONTINUED ON TO THE SECOND TRAJECTORY. WHEN THE SECOND TRAJECTORY (RIGHT) POSITIONING WAS CHECKED WITH AN O-ARM SPIN, IT WAS NOTED THE FIRST TRAJECTORY (LEFT) WAS SHALLOWER AND EXTREMELY DEVIATED INTO THE VENTRICLE. THE SURGEON TRIED TO PLACE THE ELECTRODE BACK IN POSITION, DRIVING TO THE LEFT TRAJECTORY AGAIN. THE SURGEON ALSO TRIED TWO DIFFERENT TRAJECTORIES, ONE IN THE LATERAL HOLE OF THE STARDRIVE MICRODRIVE BEN-GUN AND ANOTHER NEW ROSA TRAJECTORY. THE FINAL TRAJECTORY WAS STILL DEVIATED FROM THE INTENDED TARGET BUT SURGEON CONTINUED ON AND CLOSED UP. THE SURGEON HAS SINCE DECIDED TO REPLACE THE LEFT ELECTRODE AT A LATER DATE. CASE END WAS DELAYED SEVERAL HOURS. SURGEON MENTIONED IT APPEARED THE CANNULA PUSHED THE BRAIN TO THE SIDE INSTEAD OF PIERCING THROUGH TISSUE AFTER GOING THROUGH THE LEFT VENTRICLE. THEN ONCE THE CANNULA WAS REMOVED THE ELECTRODE FLOATED INTO THE VENTRICLE. THE REVISION TO REPLACE THE LEFT ELECTRODE WAS PERFORMED FOUR DAYS AFTER THE INITIAL AND WAS SUCCESSFUL. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME." }, { "mdr_text_key": "348832788", "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": "348832789", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "LOG FILES WERE PROVIDED AND REVIEWED. ANALYSIS OF THE LOGS FOUND THAT THE ACTUAL ENTRY POINTS FOR BOTH ELECTRODES WERE WITHIN SPECIFICATION OF THE SYSTEM. THE ROSA DEVICE FUNCTIONED AS INTENDED. THERE WERE NO SOFTWARE ANOMALIES IDENTIFIED WHICH WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. HOWEVER, REVIEW OF THE LOG FILES AND SCREENSHOTS FOUND THAT REGISTRATION VERIFICATION PROCESS WAS NOT OPTIMAL, WHICH CAN IMPACT SYSTEM PERFORMANCE AND ACCURACY. THE LOGS INDICATE THAT POINTS 2 THROUGH 7 OF THE REGISTRATION VERIFICATION WERE VALIDATED DESPITE ERRORS BEING ABOVE THRESHOLD OR SKIPPED ENTIRELY. THESE CHOICES GO AGAINST WHAT IS OUTLINED IN ROSA ONE BRAIN APPLICATION USER MANUAL, WHICH STATES: ¿THE USER MUST POSITION THE POINTER PROBE OR THE OPTICAL DISTANCE SENSOR ON SEVERAL RELEVANT ANATOMIC LANDMARKS OF THE PATIENT¿S HEAD AND VERIFY THE APPROPRIATE MATCHING OF THE NAVIGATED POSITION ON THE PREOPERATIVE IMAGES.¿ ¿IT IS HIGHLY RECOMMENDED TO CARRY OUT THE VERIFICATION IN ORDER TO OBTAIN OPTIMAL PERFORMANCE.\" IN ADDITION, THE LOGS SHOW THE SOFTWARE NOTIFIED THE USER THAT ¿A SIGNIFICANT ERROR HAS BEEN DETECTED ON THIS POINT¿ FOR THE SIX VERIFICATION POINTS THAT WERE ABOVE THE THRESHOLD. IN THE ROSA ONE BRAIN APPLICATION USER MANUAL, IT RECOMMENDS THAT IF TOO HIGH OF AN ERROR IS DETECTED ON A POINT DURING THE VERIFICATION PROCESS, THE USER SHOULD VISUALLY CHECK THE POINT AND REDO REGISTRATION, IF NECESSARY. IN THIS CASE, THE USER CHOSE TO VALIDATE THE HIGH ERRORS AND PROCEED WITH THE CASE, WHICH IS NOT ADVISED. DEVICE HISTORY RECORDS WERE NOT REVIEWED AS NO FAILURE WITH THE DEVICE WAS DETECTED. BASED ON THE INVESTIGATION PERFORMED NO FAILURE OF THE ROSA DEVICE WAS DETECTED. HOWEVER, THE LOGS CONFIRM A USER ERROR IN THE VERIFICATION PROCESS THAT CAN CONTRIBUTE TO NEGATIVE SYSTEM PERFORMANCE/ACCURACY. 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": "379945018", "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": "379945019", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "NO FURTHER INFORMATION 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": "07/31/2024;07/22/2025" } ] }