{ "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": "3009185973-2018-00151", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20180515", "manufacturer_address_2": "", "pma_pmn_number": "PK101791", "date_of_event": "20180509", "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": "20180515", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "357290", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20180515", "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": [ "Patient Data Problem", "Patient Data Problem" ], "reporter_state_code": "GA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "12/07/2018", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250807", "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": "20180515", "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": "20181226", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "7513641", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20180509", "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": "108228938", "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": "108228939", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT REGISTRATION FAILED TWICE DUE TO THE IMAGE USED FOR THE 3D RECONSTRUCTION. WHEN A DIFFERENT IMAGE WAS USED, THE REGISTRATION WAS COMPLETED SUCCESSFULLY, AND THE CASE CONTINUED AS PLANNED. A SURGICAL DELAY OF 1 HOUR WAS REPORTED." }, { "mdr_text_key": "310464083", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT REGISTRATION FAILED TWICE DUE TO THE IMAGE USED FOR THE 3D RECONSTRUCTION. EVENT SUMMARY, DEVICE HISTORY RECORD REVIEW AND COMPLAINT HISTORY REVIEW DID NOT IDENTIFY CONTRIBUTING FACTORS. THE TECHNICAL INVESTIGATION INDICATED THAT THE MOST PROBABLE CAUSE FOR THE INCORRECT TWO FIRST LASER REGISTRATIONS IS THAT THE RECONSTRUCTION WAS NOT SATISFYING AS THE FIRST CT USED FOR THE REGISTRATION WAS TOO DIFFERENT FROM THE ACTUAL PATIENT¿S HEAD MORPHOLOGY. A REVIEW OF THE IFU CONFIRMED THAT IT STATES THAT THE 3D RECONSTRUCTION HAS TO MATCH WITH THE PATIENT MORPHOLOGY. THE EVENT WAS CAUSED BY A USE ERROR. CORRECTED/UPDATED DATA: DATE OF THIS REPORT. DATE RECEIVED BY MANUFACTURER (INVESTIGATION COMPLETED). IF FOLLOW-UP, WHAT TYPE. DEVICE EVALUATED BY MANUFACTURER. EVALUATION CODE. ADDITIONAL NARRATIVES/DATA." }, { "mdr_text_key": "310464084", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT REGISTRATION FAILED TWICE DUE TO THE IMAGE USED FOR THE 3D RECONSTRUCTION. WHEN A DIFFERENT IMAGE WAS USED, THE REGISTRATION WAS COMPLETED SUCCESSFULLY, AND THE CASE CONTINUED AS PLANNED. A SURGICAL DELAY OF 1 HOUR WAS REPORTED." } ], "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": "12/26/2018" } ] }