{ "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": "I", "report_to_fda": "N", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "3009185973-2020-00148", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20200618", "manufacturer_address_2": "", "pma_pmn_number": "K182417", "date_of_event": "20200506", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "OTHER HEALTH CARE PROFESSIONAL", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "COMPANY REPRESENTATIVE", "HEALTH" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20200618", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "633765", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20200618", "brand_name": "ROSA ONE", "generic_name": "COMPUTER-ASSISTED SURGICAL DEVICE", "manufacturer_d_name": "MEDTECH SA", "manufacturer_d_address_1": "ZAC EUREKA", "manufacturer_d_address_2": "900 RUE DU MAS DE VERCHANT", "manufacturer_d_city": "MONTPELLIER, LANGUEDOC-ROUSSILLON", "manufacturer_d_state": "", "manufacturer_d_zip_code": "34000", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "FR", "manufacturer_d_postal_code": "34000", "device_operator": "HEALTH PROFESSIONAL", "model_number": "ROSA ONE", "catalog_number": "ROSAS00203", "lot_number": "3.1.1.1295", "other_id_number": "", "device_availability": "Yes", "device_report_product_code": "HAW", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "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", "Malposition of Device" ], "reporter_state_code": "FL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "09/04/2020;12/21/2020", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250805", "health_professional": "", "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": "20200618", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Intracranial Hemorrhage", "Intracranial Hemorrhage" ] } ], "distributor_city": "", "date_report": "20201221", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10168244", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20200610", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "319940245", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "THE NEUROLOGIST, TOLD THE COMPANY FIELD SERVICE ENGINEER (FSE) DURING A CASE ON 10 JUNE 2020 THAT DURING THE CASE ON (B)(6) 2020 THAT 3 ELECTRODES TURNED OUT TO BE SHALLOW OF THE PLANNED TARGET. EACH BOLT PLACEMENT WAS ALSO SHIFTED 2-3 MM TOWARDS THE TOP OF THE SKULL. THE CASE MENTIONED ON (B)(6) 2020 WAS AN INDEPENDENT CASE DONE BY THE SITE VIA FACETIME SUPPORT. THERE WAS ALSO A BRAIN BLEED THAT OCCURRED IN AN AREA THAT WAS NOT NEAR TRAJECTORIES. THE PATIENT DID NOT HAVE ANY HARM DUE TO THESE COMPLICATIONS. THE NEUROLOGIST WAS NOT SURE OF THE ORIGIN OF THE BLEED. THE BLEED WAS LEFT ALONE AND WAS CONSIDERED MINOR BY THE NEUROLOGIST. THE ELECTRODES WERE LEFT IN THE SKULL FOR RECORDING. THE PROGRESS OF THE RECORDING OR IF ANY SEIZURES HAVE BEEN RECORDED IS UNKNOWN. THE FSE DESCRIBED THAT THE PLACEMENT OF THE BOLTS BEING OFF COULD BE DUE TO A HEAD SHIFT FROM USING A MAYFIELD FRAME INSTEAD OF A CRW OR LEKSELL SINCE EVERY SINGLE BOLT WAS SHIFTED THE SAME ABOUT IN COMPARISON TO THE PLAN. THE FSE ALSO MENTIONED THAT THE DEPTH MAY HAVE BEEN HUMAN ERROR WHILE DOING CALCULATIONS." }, { "mdr_text_key": "195920083", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE DEVICE HAS NOT BEEN EVALUATED YET FOR INVESTIGATION PURPOSE. ONCE THE EVALUATION IS PERFORMED, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED. UNIQUE IDENTIFIER (UDI) #: (B)(4)." }, { "mdr_text_key": "195920084", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THE NEUROLOGIST, TOLD THE COMPANY FIELD SERVICE ENGINEER (FSE) DURING A CASE ON (B)(6) 2020 THAT DURING THE CASE ON (B)(6) 2020 THAT 3 ELECTRODES TURNED OUT TO BE SHALLOW OF THE PLANNED TARGET. EACH BOLT PLACEMENT WAS ALSO SHIFTED 2-3 MM TOWARDS THE TOP OF THE SKULL. THE CASE MENTIONED ON (B)(6) 2020 WAS AN INDEPENDENT CASE DONE BY THE SITE VIA FACETIME SUPPORT. THERE WAS ALSO A BRAIN BLEED THAT OCCURRED IN AN AREA THAT WAS NOT NEAR TRAJECTORIES. THE PATIENT DID NOT HAVE ANY HARM DUE TO THESE COMPLICATIONS. THE NEUROLOGIST WAS NOT SURE OF THE ORIGIN OF THE BLEED. THE BLEED WAS LEFT ALONE AND WAS CONSIDERED MINOR BY THE NEUROLOGIST. THE ELECTRODES WERE LEFT IN THE SKULL FOR RECORDING. THE PROGRESS OF THE RECORDING OR IF ANY SEIZURES HAVE BEEN RECORDED IS UNKNOWN. THE FSE DESCRIBED THAT THE PLACEMENT OF THE BOLTS BEING OFF COULD BE DUE TO A HEAD SHIFT FROM USING A MAYFIELD FRAME INSTEAD OF A CRW OR LEKSELL SINCE EVERY SINGLE BOLT WAS SHIFTED THE SAME ABOUT IN COMPARISON TO THE PLAN. THE FSE ALSO MENTIONED THAT THE DEPTH MAY HAVE BEEN HUMAN ERROR WHILE DOING CALCULATIONS." }, { "mdr_text_key": "321686097", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "A FULL ANALYSIS OF THE DATA LOGS HAS BEEN PERFORMED. THIS ANALYSIS FOCUSED ON THE ERROR AT THE ENTRY POINT AND CONCLUDED THAT ALL TWELVE ELECTRODES WERE IMPLANTED INACCURATELY WITH A SIMILAR SHIFT AT THE ENTRY POINT. INDEED, THE ANALYSIS CONFIRMED THAT THE SHIFT WAS SIMILAR IN VALUE AND IN DIRECTION FOR ALL TRAJECTORIES. THEREFORE, IT IS SUSPECTED THAT THE HEAD HOLDER SYSTEM ALLOWED FOR SOME MECHANICAL PLAY RESULTING IN A POSTERIOR HEAD SHIFT BEFORE STARTING THE BOLTS IMPLANTATION, AS SUGGESTED BY THE COMPLAINT DESCRIPTION. HOWEVER THIS HYPOTHESIS COULD NOT BE CONFIRMED. THE PREVENTIVE MAINTENANCE WAS PERFORMED FIVE DAYS BEFORE EVENT AND PASSED. THREE ASSISTED SURGERIES OCCURRED AFTER THE CASE AND NO COMPLAINT WAS REPORTED REGARDING THE DEVICE ACCURACY. THEREFORE IT IS PROBABLE THAT THE DEVICE BEHAVED AS EXPECTED ON THE EVENT DAY." }, { "mdr_text_key": "321686098", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "THE NEUROLOGIST, TOLD THE COMPANY FIELD SERVICE ENGINEER (FSE) DURING A CASE ON (B)(6) 2020 THAT DURING THE CASE ON (B)(6) 2020 THAT 3 ELECTRODES TURNED OUT TO BE SHALLOW OF THE PLANNED TARGET. EACH BOLT PLACEMENT WAS ALSO SHIFTED 2-3 MM TOWARDS THE TOP OF THE SKULL. THE CASE MENTIONED ON (B)(6) 2020 WAS AN INDEPENDENT CASE DONE BY THE SITE VIA FACETIME SUPPORT. THERE WAS ALSO A BRAIN BLEED THAT OCCURRED IN AN AREA THAT WAS NOT NEAR TRAJECTORIES. THE PATIENT DID NOT HAVE ANY HARM DUE TO THESE COMPLICATIONS. THE NEUROLOGIST WAS NOT SURE OF THE ORIGIN OF THE BLEED. THE BLEED WAS LEFT ALONE AND WAS CONSIDERED MINOR BY THE NEUROLOGIST. THE ELECTRODES WERE LEFT IN THE SKULL FOR RECORDING. THE PROGRESS OF THE RECORDING OR IF ANY SEIZURES HAVE BEEN RECORDED IS UNKNOWN. THE FSE DESCRIBED THAT THE PLACEMENT OF THE BOLTS BEING OFF COULD BE DUE TO A HEAD SHIFT FROM USING A MAYFIELD FRAME INSTEAD OF A CRW OR LEKSELL SINCE EVERY SINGLE BOLT WAS SHIFTED THE SAME ABOUT IN COMPARISON TO THE PLAN. THE FSE ALSO MENTIONED THAT THE DEPTH MAY HAVE BEEN HUMAN ERROR WHILE DOING CALCULATIONS." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "09/30/2020;12/21/2020" } ] }