{ "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": "3009185973-2022-00004", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20220202", "manufacturer_address_2": "", "pma_pmn_number": "K200511", "date_of_event": "20211109", "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": "1378524", "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": "R", "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": "02/23/2022", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20250807", "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": "20220228", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "FR", "manufacturer_contact_city": "JACKSONVILLE", "mdr_report_key": "13421128", "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": "288026136", "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": "288026137", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THERE WERE IDENTIFIED INACCURACIES AT THE ENTRY POINTS DURING 3 RECENT BIOPSY SURGERIES PERFORMED WITH THE ROSA DEVICE. 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": "328224429", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "A FULL ANALYSIS OF THE DEVICE DATA LOGS AND OF THE PATIENT EXAMS HAS BEEN PERFORMED. THIS ANALYSIS CONCLUDED THAT THE POST-OPERATIVE SCANS COULD NOT BE ANALYZED BECAUSE THEY WERE ACQUIRED WITH A GANTRY TILT, WHICH IS INCOMPATIBLE WITH THE ROSA SOFTWARE. THEREFORE, THE INACCURACY AT THE ENTRY POINT COULD NOT BE CONFIRMED. MOREOVER, THE USER DID NOT VERIFY EITHER THE ACCURACY AT THE ENTRY POINTS ON THE POST-OPERATIVE SCANS, BUT ONLY NOTICED AN INACCURACY AT THE TARGET POINT. THIS IS MAINLY DEPENDENT ON ELEMENTS OTHER THAT THE ROSA DEVICE, SUCH AS THE METHOD OF IMPLANTATION. NO ROBOTIC ERROR WAS FOUND DURING ANALYSIS. IT CAN BE NOTED THAT THE MATCHING FRAME SHOWED THAT THE REGISTRATION WAS NOT OPTIMAL. A MESSAGE INDICATED SIGNIFICANT DIFFERENCE BETWEEN THE IMAGE POINTS AND THE ROBOT POINTS TAKEN DURING PRE-REGISTRATION. FIVE OUT OF SEVEN VERIFICATION POINTS WERE NOT VERIFIED ON THE RECOMMENDED ANATOMICAL STRUCTURES. ADDITIONALLY, ONE HEAD HOLDER USED ON SITE WAS FOUND TO BE DEFECTIVE, AND MAY HAVE BEEN USED FOR THE CASE. THESE ELEMENTS COULD HAVE CONTRIBUTED TO A POTENTIAL INACCURACY AT THE ENTRY POINT." }, { "mdr_text_key": "328224430", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THERE WERE IDENTIFIED INACCURACIES AT THE ENTRY POINTS DURING 3 RECENT BIOPSY SURGERIES PERFORMED WITH THE ROSA DEVICE. 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": "02/28/2022" } ] }