{ "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": "3009185973-2018-00363", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20190109", "manufacturer_address_2": "", "pma_pmn_number": "K101791", "date_of_event": "20181211", "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": "SP", "manufacturer_contact_area_code": "", "date_added": "20190109", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "22818", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20190109", "brand_name": "ROSA", "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", "catalog_number": "N/A", "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": "06/03/2019", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250731", "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": "20190109", "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": "20190612", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "8230253", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20181211", "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": "132483718", "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": "132483719", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT THE PATIENT FOLDER COULD NOT BE USED FOR A SURGERY. THE CONTRAST VALUE WAS MODIFIED BUT AFTER THIS MODIFICATION THE PATIENT FOLDER DID NOT APPEAR ANYMORE ON THE DEVICE. THE SURGEON DECIDED TO ABORT THE SURGERY." }, { "mdr_text_key": "312105149", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT THE PATIENT FOLDER COULD NOT BE USED FOR A SURGERY. THE CONTRAST VALUE WAS MODIFIED BUT AFTER THIS MODIFICATION THE PATIENT FOLDER DID NOT APPEAR ANYMORE ON THE DEVICE. THE SURGEON DECIDED TO ABORT THE SURGERY." }, { "mdr_text_key": "312105150", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT THE PATIENT FOLDER WASN'T WORKING. AFTER CHANGING THE 3D THRESHOLD AND CONTRAST VALUE OF THE EXAM, AND RECOMPUTING THE CRC CODE, THE EXAM WAS NOT DISPLAYED ANYMORE ON THE ROBOT; THE SURGEON DECIDED TO ABORT THE SURGERY. EVENT SUMMARY, DEVICE HISTORY RECORD REVIEW AND COMPLAINT HISTORY REVIEW DID NOT IDENTIFY CONTRIBUTING FACTORS. AS PER THE COMPLAINT DESCRIPTION FROM THE FIELD SERVICE ENGINEER WHO REPORTED THE EVENT, IT COULD BE RELATED TO A KNOWN DESIGN DEFECT. HOWEVER THE EVENT IS NOT VERIFIABLE AND THIS POTENTIAL ROOT CAUSE CANNOT BE CONFIRMED AS NO DATA CORRESPONDING TO THE DATE OF THE SURGERY WAS FOUND ON THE DEVICE COMPUTER." } ], "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": "06/21/2019" } ] }