{ "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": "", "report_to_fda": "N", "manufacturer_contact_t_name": "MR.", "manufacturer_contact_state": "FL", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "MAUGUIO, LANGUEDOC-ROUSSILLON", "manufacturer_contact_address_1": "1520 TRADEPORT DRIVE", "manufacturer_contact_pcity": "90474144", "event_type": "Injury", "report_number": "3009185973-2022-00005", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20220202", "manufacturer_address_2": "", "pma_pmn_number": "K200511", "date_of_event": "20211102", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "32218", "reporter_occupation_code": "OTHER HEALTH CARE PROFESSIONAL", "manufacturer_contact_plocal": "9047414400", "noe_summarized": "1", "manufacturer_contact_l_name": "SHARMA", "source_type": [ "Health Professional", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "34130", "manufacturer_g1_state": "", "reporter_country_code": "FR", "manufacturer_contact_area_code": "904", "date_added": "20220202", "manufacturer_contact_f_name": "JAY", "device_date_of_manufacturer": "20200916", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1316396", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "U", "date_received": "20220202", "brand_name": "ROSA ONE", "generic_name": "COMPUTER-ASSISTED SURGICAL DEVICE", "manufacturer_d_name": "MEDTECH SAS", "manufacturer_d_address_1": "432 RUE DU RAJOL", "manufacturer_d_address_2": "", "manufacturer_d_city": "MAUGUIO, LANGUEDOC-ROUSSILLON", "manufacturer_d_state": "", "manufacturer_d_zip_code": "34130", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "FR", "manufacturer_d_postal_code": "34130", "device_operator": "HEALTH PROFESSIONAL", "model_number": "ROSA ONE", "catalog_number": "ROSAS00201", "lot_number": "3.1.5.28", "other_id_number": "", "device_availability": "Yes", "device_report_product_code": "HAW", "device_age_text": "DA", "device_evaluated_by_manufacturer": "Y", "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": [ "Imprecision", "Imprecision" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "05/06/2022", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20250806", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "9047", "patient": [ { "patient_sequence_number": "1", "date_received": "20220202", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Clinical Signs, Symptoms or Conditions", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20220513", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "FR", "manufacturer_contact_city": "JACKSONVILLE", "mdr_report_key": "13421124", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20220103", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "34130", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "MEDTECH SAS", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "N", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "288026236", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "CONCERNING THE 3 BIOPSIES PERFORMED, THE PROCEDURE DID NOT POSE ANY PARTICULAR PROBLEM, THE FIXATION WAS WITH A MAYFIELD HEAD HOLDER IN CLASSIC DECUBITUS, THERE WAS NO HEMORRHAGIC COMPLICATION OBJECTIFIED AT THE POSTOPERATIVE CONTROL CT SCAN. ON THE OTHER HAND, THE ANALYSIS OF THE SAMPLES WAS NEGATIVE, REQUIRING A SECOND SURGICAL INTERVENTION TO OBTAIN THE DIAGNOSIS, AND THEREFORE A DELAY IN ONCOLOGICAL MANAGEMENT OF ABOUT ONE MONTH." }, { "mdr_text_key": "288026277", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE DEVICE HAS NOT BEEN EVALUATED YET FOR INVESTIGATION PURPOSE. ONCE THE EVALUATION IS PERFORMED, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED. UNIQUE IDENTIFIER (UDI) #: (B)(4)." }, { "mdr_text_key": "328981095", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "A FULL ANALYSIS OF THE DATA LOGS HAS BEEN PERFORMED AND THIS ANALYSIS CONCLUDED THAT THE INACCURACY IS CONFIRMED FOR THE BIOPSY TRAJECTORY WITH A DEVIATION ESTIMATED AT 4.35MM. ALTHOUGH THE CONTACTLESS REGISTRATION WAS RESTARTED ONCE, THE FINAL ONE WAS PROPERLY PERFORMED. THE VERIFICATION HAD TO BE RESTARTED AND PASSED AFTER AN UNEXPECTED SOFTWARE INTERRUPTION DUE TO A SINGULARITY DETECTED IN COOPERATIVE MODE. THIS ISSUE WAS ALREADY ADDRESSED THROUGH THE CONTINUOUS IMPROVEMENT PROCESS OF OUR PRODUCTS NO ROBOTIC ERROR WHICH COULD LEAD TO THE INACCURACY FOUND IN THE ANALYSIS WAS IDENTIFIED BUT IT IS POSSIBLE THAT THE HEAD HOLDER USED HAD A PLAY ON ITS MOUNTING AND THAT THE HEAD MOVED DURING THE SURGERY. OTHER SIMILAR PROCEDURES USING THE SAME DEVICE AND TOOLS WERE PERFORMED FOR THE THREE FOLLOWING MONTHS WITH CORRECT ACCURACY. HOWEVER, USERS WERE NOT ABLE TO IDENTIFY WHICH HEAD HOLDER WAS USED FOR WHICH CASE." }, { "mdr_text_key": "328981096", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "CONCERNING THE 3 BIOPSIES PERFORMED, THE PROCEDURE DID NOT POSE ANY PARTICULAR PROBLEM, THE FIXATION WAS WITH A MAYFIELD HEAD HOLDER IN CLASSIC DECUBITUS, THERE WAS NO HEMORRHAGIC COMPLICATION OBJECTIFIED AT THE POSTOPERATIVE CONTROL CT SCAN. ON THE OTHER HAND, THE ANALYSIS OF THE SAMPLES WAS NEGATIVE, REQUIRING A SECOND SURGICAL INTERVENTION TO OBTAIN THE DIAGNOSIS, AND THEREFORE A DELAY IN ONCOLOGICAL MANAGEMENT OF ABOUT ONE MONTH." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "432 RUE DU RAJOL", "distributor_zip_code": "", "manufacturer_contact_postal_code": "32218", "manufacturer_contact_exchange": "904", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "05/13/2022" } ] }