{ "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": "3009185973-2018-00068", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20180308", "manufacturer_address_2": "", "pma_pmn_number": "PK101791", "date_of_event": "20180219", "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": "20180308", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "169153", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20180308", "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", "catalog_number": "RO13023", "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": [ "Computer Software Problem", "Computer Software Problem" ], "reporter_state_code": "TX", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "10/30/2018", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250805", "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": "20180308", "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": "20181108", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "7323035", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20180219", "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": "101839927", "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. NO CODE AVAILABLE' WAS SELECTED AS THERE WAS A DELAY GREATER THAN 30 MINUTES ON THE SURGERY DUE TO THIS EVENT." }, { "mdr_text_key": "101839928", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "SURGEON REPORTED THAT HE COULD NOT RETRIEVE IMAGES FROM THE PACS. HE STATED THAT HE ATTEMPTED TO RETRIEVE IMAGES FROM 4 DIFFERENT PORTS WITHIN THE OR AND THAT NONE OF THE PORTS WORKED. HE STATED THAT THIS HAS CAUSED A 1 HOUR DELAY." }, { "mdr_text_key": "166704293", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "EVENT SUMMARY, DEVICE HISTORY RECORD REVIEW AND COMPLAINT HISTORY REVIEW DID NOT IDENTIFY CONTRIBUTING FACTORS. INVESTIGATION OF THE DATA LOG FILES CONFIRMED A FIRST CRASH OCCURRED WHEN THE USER ATTEMPTED TO LOAD CT SCANS FROM PACS DUE TO THE A KNOWN DESIGN DEFECT. IT ALSO INDICATED THAT AFTERWARDS SERIES WERE REJECTED BECAUSE THE INFORMATION ON PIXEL DIMENSIONS WAS UNREADABLE BY THE SOFTWARE. THE CAUSE FOR THIS UNFOUND INFORMATION CANNOT BE DETERMINED DUE TO THE DICOM NOT AVAILABLE FOR INVESTIGATION." }, { "mdr_text_key": "166704334", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "SURGEON REPORTED THAT HE COULD NOT RETRIEVE IMAGES FROM THE PACS. HE STATED THAT HE ATTEMPTED TO RETRIEVE IMAGES FROM 4 DIFFERENT PORTS WITHIN THE OR AND THAT NONE OF THE PORTS WORKED. HE STATED THAT THIS HAS CAUSED A 1 HOUR DELAY." } ], "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": "11/08/2018" } ] }