{ "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": "3009185973-2017-00476", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20170410", "manufacturer_address_2": "", "pma_pmn_number": "K101791", "date_of_event": "20160401", "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": [ "HEALTH PROFESSIONAL" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20170410", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "258808", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20170410", "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": "", "lot_number": "", "other_id_number": "", "device_availability": "Yes", "device_report_product_code": "HAW", "device_age_text": "", "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", "Imprecision" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250827", "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": "20170410", "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": "20170406", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "6476216", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20160401", "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": "72237127", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE DEVICE RO 14 041 WAS INSPECTED FOR INVESTIGATION PURPOSE. THE DEVICE WAS FOUND FULLY FUNCTIONAL. THE INVESTIGATION IDENTIFIED THAT THE USER DID NOT FOLLOW THE RECOMMENDATIONS AND THE FOLLOWING CONTRIBUTORY ROOT CAUSES WERE IDENTIFIED : REGISTRATION ERROR ABOVE THRESHOLD AND UNDETECTED MOVEMENT OF PATIENT HEAD DUE TO HEAD FIXATION. (B)(4)." }, { "mdr_text_key": "72237128", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT HAS BEEN REPORTED THAT \"SURGEON IMPLANTED A (B)(6) PATIENT WITH TWO VISUALASE LASER FIBERS FOR A HYPOTHALAMIC HAMARTOMA. DUE TO THE PATIENT'S AGE, THE PATIENT WAS STABILIZED IN A SEGUIDA HEADFRAME AND THE ROSA WAS ATTACHED TO THE BED. REGISTRATION WAS PERFORMED WITH 6 BONE FIDUCIALS AND AN RMS OF APPROX. 1.1 MM WAS ACQUIRED. DURING THE SCRUB, IT APPEARED THAT THE PATIENT'S SCALP MAY HAVE SHIFTED A BIT. THE SURGEON WAS FINE WITH STABILITY OF THE PATIENT'S HEAD. AFTER SCRUB, EACH LASER FIBER (ONE LEFT, ONE RIGHT) WAS IMPLANTED AND THE PATIENT WAS TAKEN TO MR. UPON FUSING THE POST-OP MR, IT WAS NOTICED THAT EACH IMPLANT WAS APPROXIMATELY 3.5 MM POSTERIOR TO THE PLAN." } ], "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": "" } ] }