{ "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": "3009185973-2020-00115", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20200401", "manufacturer_address_2": "", "pma_pmn_number": "K182417", "date_of_event": "20200317", "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": "20200401", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "377404", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20200401", "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": [ "Computer Software Problem", "Computer Software Problem" ], "reporter_state_code": "MO", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "04/28/2020", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250812", "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": "20200401", "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": "20200430", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "9911077", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20200317", "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": "318000923", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "THE PATIENT WAS ATTACHED TO THE ROSA SUPPORT ARM AND POSITIONED SUPINE, WITH ABOUT A 15 DEGREE LATERAL TURN OF THE HEAD TO THE PATIENT¿S LEFT. SURGEONS USED THE O-ARM 2 TO GET A SCAN OF THE PATIENT WITH THE LEKSELL AND RADIOLUCENT BOX, THEN LOADED THE SCAN INTO THE ROSA SOFTWARE. HOWEVER, WHEN SURGEON CHOSE \"FRAME REGISTRATION\" IN THE EXAM MANAGER AND MARKED THE POINTS, THE SOFTWARE GAVE THE ERROR THAT IT COULD NOT PROPAGATE THE MARKERS THROUGH THE SLICES WHEN \"PROPAGATION\" WAS SELECTED (9:00AM). A SECOND SCAN WITH THE O-ARM 2 WAS TAKEN, THIS TIME WITH SLIGHTLY DIFFERENT PARAMETERS, BUT THE SAME ERROR APPEARED. SURGEONS WERE FORCED TO SWITCH TO MARKER REGISTRATION OFF THE LEKSELL POSTS BECAUSE THEY DID NOT WANT TO EXPOSE THE PATIENT TO ANOTHER CT SCAN. AFTER REGISTRATION WAS COMPLETE, THE SURGERY PROCEEDED WITHOUT ANY FURTHER INCIDENTS AND THE SURGEONS WERE HAPPY WITH PLACEMENT OF THE LASER FIBERS. PATIENT WAS ALREADY UNDER ANESTHESIA, BEFORE FIRST INCISION, NO IMPACT TO PATIENT, DELAY TO CASE 30 MINS." }, { "mdr_text_key": "318000924", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "DHR REVIEW AND REVIEW OF COMPLAINT HISTORY WERE NOT PERFORMED BASED ON THE LOW SEVERITY OF THIS COMPLAINT. A DETAILED ANALYSIS OF SOFTWARE LOGS WAS PERFORMED AND IT SHOWED THAT THE ERROR IS CAUSED BY THE SOFTWARE¿S MISMANAGEMENT OF AN EXAM WHICH WAS ACQUIRED WITH A LEKSELL FRAME ROTATION. THIS IS A SOFTWARE ANOMALY. THE PROBLEM COULD HAVE BEEN AVOIDED IF A CT IN WHICH THE LEKSELL FRAME IS ALIGNED WITH THE LANDMARK DISPLAYED IN THE ROSA SOFTWARE HAD BEEN USED. CORRECTED DATA: B4 DATE OF THIS REPORT, G4 DATE RECEIVED BY MANUFACTURER, H2 IF FOLLOW-UP, WHAT TYPE, H3 DEVICE EVALUATED BY MANUFACTURER, AND H6 EVENT PROBLEM AND EVALUATION CODES." }, { "mdr_text_key": "193916274", "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": "193916275", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THE PATIENT WAS ATTACHED TO THE ROSA SUPPORT ARM AND POSITIONED SUPINE, WITH ABOUT A 15 DEGREE LATERAL TURN OF THE HEAD TO THE PATIENT¿S LEFT. SURGEONS USED THE O-ARM 2 TO GET A SCAN OF THE PATIENT WITH THE LEKSELL AND RADIOLUCENT BOX, THEN LOADED THE SCAN INTO THE ROSA SOFTWARE. HOWEVER, WHEN SURGEON CHOSE \"FRAME REGISTRATION\" IN THE EXAM MANAGER AND MARKED THE POINTS, THE SOFTWARE GAVE THE ERROR THAT IT COULD NOT PROPAGATE THE MARKERS THROUGH THE SLICES WHEN \"PROPAGATION\" WAS SELECTED (9:00AM). A SECOND SCAN WITH THE O-ARM 2 WAS TAKEN, THIS TIME WITH SLIGHTLY DIFFERENT PARAMETERS, BUT THE SAME ERROR APPEARED. SURGEONS WERE FORCED TO SWITCH TO MARKER REGISTRATION OFF THE LEKSELL POSTS BECAUSE THEY DID NOT WANT TO EXPOSE THE PATIENT TO ANOTHER CT SCAN. AFTER REGISTRATION WAS COMPLETE, THE SURGERY PROCEEDED WITHOUT ANY FURTHER INCIDENTS AND THE SURGEONS WERE HAPPY WITH PLACEMENT OF THE LASER FIBERS. PATIENT WAS ALREADY UNDER ANESTHESIA, BEFORE FIRST INCISION, NO IMPACT TO PATIENT, DELAY TO CASE 30 MINS." } ], "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": "04/30/2020" } ] }