{ "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": "3009185973-2021-00070", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20210311", "manufacturer_address_2": "", "pma_pmn_number": "K200511", "date_of_event": "20210219", "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": "20210311", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "358435", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "U", "date_received": "20210311", "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 3.1", "catalog_number": "ROSAS00203", "lot_number": "3.1.4.1650", "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": "CA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "05/04/2021", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250807", "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": "20210311", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Clinical Signs, Symptoms or Conditions", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20210507", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "11461935", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20210219", "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": "323855323", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "A DETAILED ANALYSIS OF THE DATA LOGS HAS BEEN PERFORMED AND LED TO THE FOLLOWING OBSERVATIONS: FOUR REGISTRATIONS WERE ATTEMPTED. ALL COMPUTED REGISTRATION RESULTS WERE CORRECT AND WITHIN SPECIFICATION LIMITS. EACH TIME, MULTIPLE POINTS WERE VERIFIED ON ANTERIOR FIDUCIALS AND PROVIDED CORRECT RESULTS, WHICH PERMIT TO ASSUME THAT THE DEVICE BEHAVED AS EXPECTED. FEW OF THEM WERE VERIFIED AT THE VERY LIMIT OF THE POSTERIOR PART OF THE HEAD ¿ STILL ON FIDUCIALS - AND DID NOT PROVIDE CORRECT RESULTS. HOWEVER, FEW OF THEM WERE NOT CLEAR ON VERIFICATION SCREENSHOTS WHICH DOES NOT PERMIT TO ANALYZE THEM. THE LAST POINTS OF VERIFICATION WERE NOT VERIFIED AT ALL. GLOBALLY, THE ANALYSIS CONFIRMS THAT THE REGISTRATION VERIFICATION WAS NOT CORRECTLY PERFORMED AS LESS POINTS THAN REQUIRED WERE VERIFIED, AND BONE FIDUCIALS WERE USED FOR THIS VERIFICATION INSTEAD OF THE RECOMMENDED LANDMARKS ON THE PATIENT¿S FACE. MOREOVER, THE 3D SEGMENTATION OF THE PATIENT¿S FACE WAS NOT ENOUGH CLEAR TO PERMIT A CORRECT VERIFICATION. THE MERGE OF AN O-ARM EXAM REQUIRED TO BE ADJUSTED MANUALLY, AND THE RECALCULATE FUNCTION DID NOT PERMIT TO GET A BETTER RESULT. THIS IS A KNOWN SOFTWARE LIMITATION THAT WILL BE ADDRESSED THROUGH OUR CONTINUOUS IMPROVEMENT PROCESS. NO DISTORTION WAS FOUND AND THE CT SERIES WERE ACQUIRED WITHOUT GANTRY TILT. THE USER ALSO COMPLAINED ABOUT THE ADJUSTMENT OF THE CONTRAST LEVEL WHICH CANNOT BE DONE THROUGH THE SCREEN OF MERGED EXAMS. THIS WILL BE CONSIDERED AS A REQUEST FOR IMPROVEMENT, SINCE THE DEVICE BEHAVED AS INTENDED AND AS SPECIFIED." }, { "mdr_text_key": "323855324", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "AN O-ARM SCAN WAS TAKEN FOR MARKER/FIDUCIAL REGISTRATION. HOWEVER, THE IMAGE WOULD NOT MERGE AUTOMATICALLY ¿ THE IMAGE WAS ROTATED (MAY BE DUE TO A GANTRY TILT). THE SURGEON HAD TO MANUALLY MERGE THE IMAGE. ALSO, PRIOR TO THIS, LEKSELL FRAME REGISTRATION WAS TRIED, AND ALTHOUGH AN ERROR OF 0.39 WAS OBTAINED, WHEN THE FOREHEAD SKIN WAS CHECKED IT WAS ABOUT 1-2 MM OFF IN DEPTH SO THAT¿S WHY REGISTRATION WAS PERFORMED A SECOND TIME WITH MARKERS. THAT ERROR COULD HAVE BEEN DUE TO A MERGE ISSUE AS WELL. THE SURGEON ALSO COMPLAINED THAT THE WINDOW AND LEVEL OF THE IMAGE/BONE WINDOW COULDN'T BE CHANGED WITHIN THE MERGE SCREEN (ONLY THE TOP LEFT IMAGE) ¿THE ONLY WAY TO CHANGE WINDOW/LEVEL OF THE ORIGINAL IMAGE WAS THROUGH THE CONTRAST BUTTON IN THE REGULAR PART OF THE SOFTWARE. ALL OF THESE IMAGING ISSUES CAUSED A 1-1.5 HOUR DELAY IN THE CASE." }, { "mdr_text_key": "239831886", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "UDI# : (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": "239831887", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AN O-ARM SCAN WAS TAKEN FOR MARKER/FIDUCIAL REGISTRATION. HOWEVER, THE IMAGE WOULD NOT MERGE AUTOMATICALLY ¿ THE IMAGE WAS ROTATED (MAY BE DUE TO A GANTRY TILT). THE SURGEON HAD TO MANUALLY MERGE THE IMAGE. ALSO, PRIOR TO THIS, LEKSELL FRAME REGISTRATION WAS TRIED, AND ALTHOUGH AN ERROR OF 0.39 WAS OBTAINED, WHEN THE FOREHEAD SKIN WAS CHECKED IT WAS ABOUT 1-2 MM OFF IN DEPTH SO THAT¿S WHY REGISTRATION WAS PERFORMED A SECOND TIME WITH MARKERS. THAT ERROR COULD HAVE BEEN DUE TO A MERGE ISSUE AS WELL. THE SURGEON ALSO COMPLAINED THAT THE WINDOW AND LEVEL OF THE IMAGE/BONE WINDOW COULDN¿T BE CHANGED WITHIN THE MERGE SCREEN (ONLY THE TOP LEFT IMAGE) ¿THE ONLY WAY TO CHANGE WINDOW/LEVEL OF THE ORIGINAL IMAGE WAS THROUGH THE CONTRAST BUTTON IN THE REGULAR PART OF THE SOFTWARE. ALL OF THESE IMAGING ISSUES CAUSED A 1-1.5 HOUR DELAY IN THE CASE." } ], "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": "05/07/2021" } ] }