{ "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": "2026-09-22", "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": "3009185973-2020-00065", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20200224", "manufacturer_address_2": "", "pma_pmn_number": "K101791", "date_of_event": "20200127", "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": "GM", "manufacturer_contact_area_code": "", "date_added": "20200224", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "210053", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20200224", "brand_name": "ROSA SURGICAL DEVICE", "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 2.5.8", "catalog_number": "ROSA", "lot_number": "2.5.8.4", "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": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "03/19/2020", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250724", "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": "20200224", "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": "20200323", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "9743812", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20200127", "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": "192656867", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE DEVICE HAS NOT BEEN EVALUATED YET FOR INVESTIGATION PURPOSE. ONCE THE EVALUATION IS PERFORMED, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED. (B)(4)." }, { "mdr_text_key": "192656868", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THE FIELD SERVICE ENGINEER (FSE) ASSISTED THE SURGEON WHILE IMPORTING THE CT INTO THE SETUP PATIENT FOLDER (RO1506620200127B). IMPORT OF THE CT WENT WELL. THEN SURGEON WANTED TO RECOGNIZE THE FRAME IN THE CT. HE RECORDED THE 9 INITIAL POINTS AND CLICKED PROPAGATION. WHEN GOING THROUGH THE SLICES, THE SURGEON AND THE FSE FOUND THAT THE MARKER JUMPS ON A PART OF THE X-RAY PROTECTION GLASSES, WHICH THE PATIENT WORE DURING THE CT ACQUISITION. SURGEON CLICKED ON PROPAGATION AND GOT AN RMS > 2 MM (RED FLAGGED). HE RESETED THE POINTS AND CHANGED THE SLICE, WHERE HE RECORDED THE INITIAL POINTS AND CLICKED PROPAGATION AGAIN. WHEN GOING THROUGH THE SLICES HE FOUND THE INITIAL POINTS CHANGED TO A BAD POINT. THE FSE AND SURGEON AGREED ON IMPORTING AGAIN ONLY A PARTIAL CT. WHEN DETECTING THE FRAME ON THE PARTIAL CT, THEY COULD ACHIEVE AN RMS OF 0,8 MM. BY CHANGING THE INITIAL SLICE THEY ACHIEVED A RMS OF 0,78 MM. THE FIRST SURGEON CLICKED ON ACCEPT. ANOTHER ASSISTED SURGEON DID NOT WANT TO ACCEPT. THEN HE TRIED TO LOAD THE SAME CT A 3. TIME, TO TRY LOADING A DIFFERENT PART OF THE CT. (B)(6) DID NOT LOAD THE SERIES ANY. MORE. THEY SET UP THE PATIENT FOLDER (RO1506620200127A) WITH ONLY A T1 AND THE FULL CT, LOADED THE UPPER PART OF THE CT. WHEN MERGING THE PARTLY CT WITH SAME COORDINATE OPTION, THE MERGE WAS NOT GOOD. THEY MERGED AUTOMATICALLY AND THE MERGE WAS NOT GOOD. THEY USED THE TOOLS IN MERGE CHECKING TO CREATE A GOOD MERGE AND WERE ABLE TO DETECT THE FRAME AFTERWARDS WITH AN RMS OF 0,48 MM. WITH THIS THEY STARTED THE SURGERY." }, { "mdr_text_key": "316430352", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "FULL ANALYSIS OF THE DATA LOGS HAS BEEN PERFORMED, THIS ANALYSIS CONCLUDED THAT THE RMS ERROR OF THE LEKSELL FRAME REGISTRATION WAS OVER THE SPECIFICATION LIMIT OF 1 MM BECAUSE A MARKER OF THE FRAME WAS CONFUSED WITH A POINT OF THE PROTECTION GLASSES. THIS IS A KNOWN ANOMALY." }, { "mdr_text_key": "316430353", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "THE FIELD SERVICE ENGINEER (FSE) ASSISTED THE SURGEON WHILE IMPORTING THE CT INTO THE SETUP PATIENT FOLDER (B)(4). IMPORT OF THE CT WENT WELL. THEN SURGEON WANTED TO RECOGNIZE THE FRAME IN THE CT. HE RECORDED THE 9 INITIAL POINTS AND CLICKED PROPAGATION. WHEN GOING THROUGH THE SLICES, THE SURGEON AND THE FSE FOUND THAT THE MARKER JUMPS ON A PART OF THE X-RAY PROTECTION GLASSES, WHICH THE PATIENT WORE DURING THE CT ACQUISITION. SURGEON CLICKED ON PROPAGATION AND GOT AN RMS > 2 MM (RED FLAGGED). HE RESET THE POINTS AND CHANGED THE SLICE, WHERE HE RECORDED THE INITIAL POINTS AND CLICKED PROPAGATION AGAIN. WHEN GOING THROUGH THE SLICES HE FOUND THE INITIAL POINTS CHANGED TO A BAD POINT. THE FSE AND SURGEON AGREED ON IMPORTING AGAIN ONLY A PARTIAL CT. WHEN DETECTING THE FRAME ON THE PARTIAL CT, THEY COULD ACHIEVE AN RMS OF 0,8 MM. BY CHANGING THE INITIAL SLICE THEY ACHIEVED A RMS OF 0,78 MM. THE FIRST SURGEON CLICKED ON ACCEPT. ANOTHER ASSISTED SURGEON DID NOT WANT TO ACCEPT. THEN HE TRIED TO LOAD THE SAME CT A 3. TIME, TO TRY LOADING A DIFFERENT PART OF THE CT. (B)(6) DID NOT LOAD THE SERIES ANY. MORE. THEY SET UP THE PATIENT FOLDER (B)(4) WITH ONLY A T1 AND THE FULL CT, LOADED THE UPPER PART OF THE CT. WHEN MERGING THE PARTLY CT WITH SAME COORDINATE OPTION, THE MERGE WAS NOT GOOD. THEY MERGED AUTOMATICALLY AND THE MERGE WAS NOT GOOD. THEY USED THE TOOLS IN MERGE CHECKING TO CREATE A GOOD MERGE AND WERE ABLE TO DETECT THE FRAME AFTERWARDS WITH AN RMS OF 0,48 MM. WITH THIS THEY STARTED THE SURGERY." } ], "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": "03/23/2020" } ] }