{ "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": "*", "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": "3009185973-2018-00091", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20180321", "manufacturer_address_2": "", "pma_pmn_number": "PK101791", "date_of_event": "20180314", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "HEALTH 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": "20180321", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "200236", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20180321", "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": "N/A", "lot_number": "2.5.8.4", "other_id_number": "N/A", "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": [ "Imprecision", "Adverse Event Without Identified Device or Use Problem", "Imprecision", "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "06/08/2018", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250813", "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": "20180321", "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": "20180611", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "7357004", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20180314", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Inspection" ], "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": "103017437", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE DEVICE HAS NOT BEEN EVALUATED YET FOR INVESTIGATION PURPOSE. ONCE THE EVALUATION WILL BE PERFORMED, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED. (B)(4)." }, { "mdr_text_key": "103017438", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "PATIENT WAS IN PRONE POSITION, REGISTERED WITH FIDUCIAL MARKERS, AND ENTRY POINTS MARKED WITH POINTER PROBE. PATIENT WAS DRAPED AND SURGEON ATTEMPTED TO DRIVE TO SEVERAL TRAJECTORIES WITH INSTRUMENT HOLDER BUT NOTICED THE ENTRY POINTS WERE DIFFERENT THAN THE ONES PREVIOUSLY MARKED. SURGEON CREATED TRAJECTORY WITH TARGET POINT INSIDE OF A FIDUCIAL MARKER, AND THE DRIVE TO THIS TARGET LOOKED ACCURATE; HOWEVER, SURGEON NOTED THAT THIS FIDUCIAL WAS FAR FROM OTHER TRAJECTORIES. NOTE: VIGILANCE DEVICE MAY HAVE MALFUNCTIONED DURING DRIVE TO PARK POSITION. PATIENT WAS UNDRAPED AND REGISTRATION REPEATED. SURGEON NOTED THAT THE BED MOVED SLIGHTLY, AND THAT THESE INACCURACIES MAY HAVE BEEN DUE TO SKIN SHIFT CAUSED BY BODY SHIFT. SURGEONS PROCEEDED WITH SURGERY AND TOLD MEDTECH REPRESENTATIVE THAT POST-OPERATIVE CT SCANS INDICATED ACCURATE PLACEMENT OF ELECTRODES AND THEREFORE NO CLINICAL CONSEQUENCES. ESTIMATED TIME LOST WAS 60 MINUTES." }, { "mdr_text_key": "291513223", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "ACCORDING TO TECHNICAL INVESTIGATION REGISTRATION AND REGISTRATION VERIFICATION WERE CONFORMING TO THE SPECIFICATIONS. IT IS POSSIBLE THAT THE MOVEMENT OF THE BED, NOTICED BY THE SURGEON DURING THE SURGERY, PROBABLY PROVOKED AN UNDETECTED INELASTIC MOVEMENT ON ONE SIDE OF THE HEAD. CORRECTED DATA: DATE OF THIS REPORT, MANUFACTURER, ADDITIONAL DEVICE INFORMATION, EVENT PROBLEM CODES - DEVICE CODE, OFFICE CONTACT - MANUFACTURING SITE, DATE RECEIVED BY MANUFACTURER, IF FOLLOW-UP, WHAT TYPE, DEVICE EVALUATED BY MANUFACTURER, EVALUATION CODE." } ], "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": "06/11/2018" } ] }