{ "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": "3009185973-2020-00278", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20201028", "manufacturer_address_2": "", "pma_pmn_number": "K200511", "date_of_event": "20201012", "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": "20201028", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1212954", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20201028", "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": "3.1.4.1650", "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": "NY", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250818", "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": "20201028", "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": "20201021", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10745742", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20201012", "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": "213476873", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "A FULL ANALYSIS OF THE DATA LOGS HAS BEEN PERFORMED AND PERMITTED TO CONFIRM THAT ALTHOUGH THE CORRECT WORKFLOW WAS FOLLOWED BY THE USER, THE FUNCTION RECALCULATE DID NOT WORK AS EXPECTED SINCE IT DID NOT PERMIT TO GET A BETTER RESULT OF THE AUTOMATIC MERGE AFTER COARSE MANUAL ADJUSTMENTS. A SOFTWARE ANOMALY HAS BEEN IDENTIFIED. THE MANUAL ADJUSTMENT WAS STILL POSSIBLE AND COULD PERMIT TO GET A CORRECT MERGE. UDI#: (B)(4)." }, { "mdr_text_key": "213476874", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "DURING BIOPSY CASE WITH DR. (B)(6), A DELAY OF 35 MINUTES TOOK PLACE PRIOR TO BONE FIDUCIAL REGISTRATION. THE PLANNING FOR THIS PROCEDURE WAS DONE USING AN MRI IMAGE AND MEDTRONIC O-ARM SPIN WAS REQUIRED FOR BONE FIDUCIAL REGISTRATION. UPON FIRST ATTEMPT, THE AUTOMATIC MERGE OF THE O-ARM CT IMAGE TO THE MRI WAS NOT ACCURATE. MACRO-ADJUSTMENTS WERE MADE AND THE \"RECALCULATE MERGE\" FUNCTION WAS ATTEMPTED WHICH CAUSED THE IMAGE TO REVERT TO THE INITIAL AUTOMATIC MERGE ATTEMPT. AT THIS TIME, DR. (B)(6) ELECTED TO GET ANOTHER O-ARM SCAN TO INCLUDE MORE OF THE SKULL WITH THE IDEA THAT THERE WOULD BE MORE DATA TO MERGE MORE ACCURATELY. UPON ATTEMPTING TO MERGE THE SECOND O-ARM SPIN, THE SAME ISSUE OCCURRED. AT THIS TIME, DR. (B)(6) REQUESTED THE PATIENT BE BROUGHT TO GET A PROPER CT SCAN. THE FIELD SERVICE ENGINEER (FSE) SUGGESTED TO MERGE TO A RECENT CT SCAN IF AVAILABLE. THE FSE WAS ABLE TO RETRIEVE A RECENT HEAD CT SCAN AND SUCCESSFULLY MERGE TO PROPER CT SCAN. ADDITIONALLY, AN INTRO-OPERATIVE O-ARM WAS REQUIRED TO ENSURE POSITION OF BIOPSY NEEDLE WHERE A 3RD O-ARM SCAN WAS MERGED TO THE PROPER CT SCAN WITH SIGNIFICANT ERROR. THE MAYFIELD HEAD CLAMP CREATED MAJOR ARTIFACT IN THE IMAGE AS EXPECTED HOWEVER, THE \"RECALCULATE MERGE\" FEATURE WAS AGAIN FAULTY WHERE THE MERGE RETURNED TO THE INITIAL AUTOMATIC MERGE AFTER MACRO-ADJUSTMENTS HAD BEEN MADE. SURGEON COMPLAINS THAT PRIOR TO 2 MONTHS AGO, THERE HAD BEEN NO ISSUES MERGING O-ARM TO MRI IMAGE." } ], "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": "" } ] }