{ "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": "3009185973-2019-00254", "type_of_report": [ "Initial submission" ], "product_problem_flag": "", "date_received": "20190722", "manufacturer_address_2": "", "pma_pmn_number": "K172444", "date_of_event": "20190624", "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": "20190722", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "606678", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20190722", "brand_name": "ROSA BRAIN", "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 BRAIN", "catalog_number": "N/A", "lot_number": "3.0.0.21", "other_id_number": "", "device_availability": "Yes", "device_report_product_code": "HAW", "device_age_text": "", "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": [ "Computer Software Problem", "Computer Software Problem" ], "reporter_state_code": "MI", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250804", "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": "20190722", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Code Available", "No Code Available" ] } ], "distributor_city": "", "date_report": "20190722", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "8811468", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20190624", "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": "151722911", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT A SURGEON HAD DIFFICULTIES TO PERFORM A FUSION AND DECIDED TO ABORT THE SURGERY. DHR REVIEW DID NOT IDENTIFY ANY CONTRIBUTORY FACTORS TO THE EVENT. COMPLAINT HISTORY REVIEW SHOWED THAT 2 SIMILAR COMPLAINTS WERE RECEIVED DURING THE PAST 12 MONTHS. ACCORDING TO TECHNICAL INVESTIGATION, IT IS CONFIRMED THAT THE EXAMS ARE DIFFICULT TO MERGE AND SOME ELEMENTS PRESENT ON THE IMAGES CAN BE THE CAUSE. HOWEVER, MANUAL ADJUSTMENTS COULD HAVE BEEN DONE TO PERFORM THE FUSION, THE IFU PROVIDES ENOUGH ELEMENTS TO PERFORM THE MANUAL ADJUSTMENTS. THEREFORE, IT CAN BE CONSIDERED AS A USE ERROR. UDI #: (B)(4)." }, { "mdr_text_key": "151722912", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "A FIELD SERVICE ENGINEER ASSISTED AT SPECTRUM HEALTH WITH AN SEEG CASE ON (B)(6) 2019 USING (B)(4). BONE FIDUCIALS WERE PLACED INTO PATIENT'S HEAD AND THE PATIENT WAS TAKEN TO GET A CT SO THE SCAN COULD BE USED FOR REGISTRATION. AFTER OBTAINING THE CT (AROUND 4:43PM EST), THE IMAGE SET WAS MERGED TO THE PRE-OP CTA SCAN USING THE AUTOMATIC FEATURE. THE SURGEON DID NOT APPROVE OF THE AUTOMATIC MERGE BETWEEN THE SCANS. THE CT WAS ALSO MERGED TO THE NEWEST MR SCAN THAT WAS UPLOADED, WHICH APPEARED TO MERGE CORRECTLY. WHEN COMPARING THE NEW CT FROM THIS MERGE WITH THE PRE-OP CTA, THERE WAS A VERY NOTICEABLE DIFFERENCE BETWEEN THE TWO SCANS. THE SURGEON WOULD LIKE TO KNOW WHY THE AUTOMATIC MERGE DID NOT WORK. TWO DIFFERENT BONE FIDUCIAL SCANS WERE UPLOADED AND ATTEMPTED TO BE MERGED, BUT NEITHER WORKED (ONE SET WAS AROUND 330 SLICES BUT WAS CUT DOWN BELOW 255 SLICES, AND THE OTHER SET WAS AROUND 210 SLICES). THE SURGEON DECIDED TO CANCEL THE CASE AND RESCHEDULE FOR (B)(6) 2019. THE PATIENT WAS UNDER ANESTHESIA AND INCISIONS WERE MADE FOR BONE FIDUCIALS. THE BONE FIDUCIALS WILL BE LEFT IN THE PATIENT'S HEAD UNTIL THE RESCHEDULED SURGERY DATE." } ], "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": "" } ] }