{ "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": "3009185973-2019-00466", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20200106", "manufacturer_address_2": "", "pma_pmn_number": "K172444", "date_of_event": "20191203", "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": "US", "manufacturer_contact_area_code": "", "date_added": "20200106", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "12931", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20200106", "brand_name": "ROSA BRAIN", "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 BRAIN 3.0", "catalog_number": "ROSAS00303", "lot_number": "3.0.0.21", "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": "MA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "01/02/2020;07/24/2020", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250811", "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": "20200106", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Consequences Or Impact To Patient", "No Code Available", "No Consequences Or Impact To Patient", "No Code Available" ] } ], "distributor_city": "", "date_report": "20200728", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "9551805", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20191210", "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": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "320049622", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "DHR REVIEW AND REVIEW OF COMPLAINT HISTORY DID NOT IDENTIFY ANY CONTRIBUTORY FACTORS TO THE EVENT. A FULL ANALYSIS OF THE DATA LOGS HAS BEEN PERFORMED AND CONCLUDED THAT THE INACCURACY OF THE IMPLANTS POSITION COMPARED TO THE ORIGINAL PLAN WAS CONFIRMED FOR BOTH TRAJECTORIES. THE IMPLANTS ARE SHIFTED IN THE SAME DIRECTION AND JOIN THE TARGET AT AN ANGLE. MULTIPLE ELEMENTS MIGHT HAVE PLAYED A ROLE INTO THE INACCURACY OF THE IMPLANTS PLACEMENT IN THIS OPERATION: THE CT PRE-OPERATIVE USED DURING THE CASE EXHIBITED A LOW IMAGE QUALITY. THE FUSION OF THE CT PRE-OPERATIVE WITH THE MRI PRE-OPERATIVE USED DURING THE CASE WAS NOT MANUALLY ADJUSTED AND WAS INACCURATE. FOUR MARKERS, INSTEAD OF FIVE MINIMUM, WERE DISTRIBUTED ON THE LEKSELL FRAME ON A SAME PLANE, AS OPPOSED TO THE RECOMMENDATIONS PROVIDED IN THE IFUS. THE REGISTRATION WAS VALIDATED WITH ERRORS AND THE VERIFICATION WAS NOT PERFORMED CORRECTLY. THE INSERTION METHOD, THE PATIENT ANATOMY AND THE IMPLANT CHARACTERISTICS CAN ALSO BE FACTORS OF INACCURACY, NOTABLY AT THE TARGET POINT. THE USER FAILED TO FOLLOW MULTIPLE RECOMMENDATIONS OF THE IFU DURING THIS CASE. ANALYSIS SHOWED THAT THE INACCURACY IS CONFIRMED." }, { "mdr_text_key": "320049623", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "SURGEON PERFORMED DBS PROCEDURE TARGETING BILATERAL VIM WITHOUT THE FIELD SERVICE ENGINEER. SURGEON AND STAFF STRUGGLED WITH OBTAINING ADEQUATE VALUE FOR FIDUCIAL RMS. REACHED OUT FOR PHONE SUPPORT TO FSE. CASE PROCEEDED NORMALLY. IT WAS NOTED DURING POST OPERATIVE IMAGING THAT DBS ELECTRODES APPEAR TO BE DEEP BY NEARLY 8 MM ON LEFT AND ON TARGET ON RIGHT." }, { "mdr_text_key": "317060703", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "CORRECTED DATA: B1 REPORT TYPE. B4 DATE OF THIS REPORT. H1 TYPE OF REPORTABLE EVENT. H6 PATIENT CODE. H6 PATIENT CODE : A REVISION SURGERY WAS PERFORMED AFTER THE EVENT OCCURRED. BASED ON THE DEFINITION OF A SERIOUS INJURY IN LOCAL PROCEDURE, THE OBSERVED CONSEQUENCE IS CONSIDERED AS A SERIOUS INJURY. THE REASON FOR WHICH THE CODE 3191 WAS CHOSEN. THE FIELD SERVICE ENGINEER PROVIDE A NEW INFORMATION ABOUT WHETHER THE REVISION SURGERY IS REALIZE OR NOT. SHE HAD CONFIRMED THAT REVISION SURGERY WAS PERFORMED AND THE LEAD WAS PULLED BACK BY SEVERAL MM DURING THE IMPLANTATION OF THE BATTERY FOR THE DBS DEVICE TO ACCOUNT FOR THE DEEP IMPLANT." }, { "mdr_text_key": "317060704", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "SURGEON PERFORMED DBS PROCEDURE TARGETING BILATERAL VIM WITHOUT THE FIELD SERVICE ENGINEER. SURGEON AND STAFF STRUGGLED WITH OBTAINING ADEQUATE VALUE FOR FIDUCIAL RMS. REACHED OUT FOR PHONE SUPPORT TO FSE. CASE PROCEEDED NORMALLY. IT WAS NOTED DURING POST OPERATIVE IMAGING THAT DBS ELECTRODES APPEAR TO BE DEEP BY NEARLY 8 MM ON LEFT AND ON TARGET ON RIGHT." }, { "mdr_text_key": "196233762", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "(B)(4). THE DEVICE HAS NOT BEEN EVALUATED YET FOR INVESTIGATION PURPOSE. ONCE THE EVALUATION IS PERFORMED, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED." }, { "mdr_text_key": "196233983", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "SURGEON PERFORMED DBS PROCEDURE TARGETING BILATERAL VIM WITHOUT THE FIELD SERVICE ENGINEER. SURGEON AND STAFF STRUGGLED WITH OBTAINING ADEQUATE VALUE FOR FIDUCIAL RMS. REACHED OUT FOR PHONE SUPPORT TO FSE. CASE PROCEEDED NORMALLY. IT WAS NOTED DURING POST OPERATIVE IMAGING THAT DBS ELECTRODES APPEAR TO BE DEEP BY NEARLY 8 MM ON LEFT AND ON TARGET ON RIGHT." } ], "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": "01/29/2020;07/29/2020" } ] }