{ "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": "3009185973-2019-00054", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20190301", "manufacturer_address_2": "", "pma_pmn_number": "K172444", "date_of_event": "20190131", "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": [ "HEALTH PROFESSIONAL" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20190301", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "175948", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20190301", "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": "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": [ "Computer Software Problem", "Computer Software Problem" ], "reporter_state_code": "MD", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "03/06/2019", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250731", "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": "20190301", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Code Available", "No Code Available" ] } ], "distributor_city": "", "date_report": "20190403", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "8382086", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20190131", "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": "312104029", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT A SURGERY HAD A DELAY GREATER THAN 30 MINUTES BECAUSE OF AN INCORRECT MERGE OF INTRA-OPERATIVE CT SCAN. DHR REVIEW AND REVIEW OF COMPLAINT HISTORY DID NOT IDENTIFY ANY CONTRIBUTORY FACTORS TO THE EVENT. ACCORDING TO TECHNICAL INVESTIGATION, THE USER SPENT 45 MINUTES TRYING TO MERGE IMAGES AUTOMATICALLY OR SEMI-AUTOMATICALLY WITHOUT USING THE MANUAL ADJUSTMENT, REPORTEDLY BECAUSE OF TIME CONCERNS. THE ADJUSTMENT FRAME WAS CREATED AND WAS AVAILABLE TO ALLOW THE USER TO READJUST THE FUSION, IF NOT SATISFACTORY. THE DEVICE WORKED AS INTENDED AND AN ACCEPTABLE ADJUSTMENT WAS POSSIBLE.THE IFU PROVIDES ALL NECESSARY INFORMATION TO PERFORM MANUAL ADJUSTMENTS AND OBTAIN AN ACCEPTABLE MERGE. IT WAS A USER DECISION NOT TO USE THIS FRAME. THE SURGEON IS CONSIDERED AS EXPERIENCED AND THE SURGERY WAS ASSISTED BY AN FSE. THE OPTION FOR MANUAL ADJUSTMENTS MIGHT HAVE BEEN RECOMMENDED, HOWEVER THE USER IS IN CHARGE OF THE FINAL DECISION. BASED ON THE INVESTIGATION PERFORMED, THERE WAS NO MALFUNCTION OF THE DEVICE. THIS EVENT WAS DUE TO A PREFERENCE OF THE CUSTOMER WHO CHOSE NOT TO USE THE MANUAL ADJUSTMENT FEATURE." }, { "mdr_text_key": "312104030", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "AT 10:04AM, CT SCAN TAKEN FROM INTRAOPERATIVE O-ARM (MEDTRONIC) DID NOT MERGE ACCURATELY WITH PRE-OPERATIVE MRI. SURGEON ATTEMPTED AUTOMATIC AND SEMI-AUTOMATIC MERGE, BOTH TO PRE-OP MRI AND TO PRE-OP CT, AND EXCLUDED UNNECESSARY SLICES, BUT PROBLEM PERSISTED. NEXT, O-ARM TECHNICIAN RE-DEFINED ORIENTATION OF AXES USING O-ARM SOFTWARE PRIOR TO EXPORT, BUT PROBLEM PERSISTED. NEXT, SURGEON ATTEMPTED TO MANUALLY CORRECT ORIENTATION OF AXES BY RE-POSITIONING THE PATIENT¿S HEAD TO BE CLOSER TO SUPINE NEUTRAL AND RE-SCANNING, BUT PROBLEM PERSISTED. SURGEON DID NOT WANT TO USE MANUAL MERGING BECAUSE OF TIME CONCERNS AND PROCEEDED TO CONTACTLESS REGISTRATION INSTEAD OF MARKERS. PATIENT WAS ANESTHETIZED, INCISIONS WERE MADE AND BONE FIDUCIALS INSERTED, ESTIMATED DELAY TO CASE IS 45 MINUTES." }, { "mdr_text_key": "137537536", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "(B)(4). THE DEVICE HAS NOT BEEN EVALUATED YET FOR INVESTIGATION PURPOSE. ONCE THE EVALUATION IS PERFORMED, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED." }, { "mdr_text_key": "137537537", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AT 10:04AM, CT SCAN TAKEN FROM INTRAOPERATIVE O-ARM (MEDTRONIC) DID NOT MERGE ACCURATELY WITH PRE-OPERATIVE MRI. SURGEON ATTEMPTED AUTOMATIC AND SEMI-AUTOMATIC MERGE, BOTH TO PRE-OP MRI AND TO PRE-OP CT, AND EXCLUDED UNNECESSARY SLICES, BUT PROBLEM PERSISTED. NEXT, O-ARM TECHNICIAN RE-DEFINED ORIENTATION OF AXES USING O-ARM SOFTWARE PRIOR TO EXPORT, BUT PROBLEM PERSISTED. NEXT, SURGEON ATTEMPTED TO MANUALLY CORRECT ORIENTATION OF AXES BY RE-POSITIONING THE PATIENT¿S HEAD TO BE CLOSER TO SUPINE NEUTRAL AND RE-SCANNING, BUT PROBLEM PERSISTED. SURGEON DID NOT WANT TO USE MANUAL MERGING BECAUSE OF TIME CONCERNS AND PROCEEDED TO CONTACTLESS REGISTRATION INSTEAD OF MARKERS. PATIENT WAS ANESTHETIZED, INCISIONS WERE MADE AND BONE FIDUCIALS INSERTED, ESTIMATED DELAY TO CASE IS 45 MINUTES." } ], "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": "04/04/2019" } ] }