{ "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": "", "report_to_fda": "N", "manufacturer_contact_t_name": "MR.", "manufacturer_contact_state": "FL", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "MAUGUIO, LANGUEDOC-ROUSSILLON", "manufacturer_contact_address_1": "1520 TRADEPORT DRIVE", "manufacturer_contact_pcity": "90474144", "event_type": "Injury", "report_number": "3009185973-2022-00038", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20220829", "manufacturer_address_2": "", "pma_pmn_number": "K214065", "date_of_event": "20220801", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "32218", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "9047414400", "noe_summarized": "1", "manufacturer_contact_l_name": "SHARMA", "source_type": [ "Health Professional", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "34130", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "904", "date_added": "20220829", "manufacturer_contact_f_name": "JAY", "device_date_of_manufacturer": "20180621", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2067380", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "U", "date_received": "20220829", "brand_name": "ROSA ONE BRAIN", "generic_name": "NEUROLOGICAL STEREOTAXIC INSTRUMENT", "manufacturer_d_name": "MEDTECH SAS", "manufacturer_d_address_1": "432 RUE DU RAJOL", "manufacturer_d_address_2": "", "manufacturer_d_city": "MAUGUIO, LANGUEDOC-ROUSSILLON", "manufacturer_d_state": "", "manufacturer_d_zip_code": "34130", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "FR", "manufacturer_d_postal_code": "34130", "device_operator": "HEALTH PROFESSIONAL", "model_number": "N/A", "catalog_number": "ROSAS00203", "lot_number": "3.1.6.90", "other_id_number": "", "device_availability": "No", "device_report_product_code": "HAW", "device_age_text": "DA", "device_evaluated_by_manufacturer": "R", "combination_product_flag": "N", "udi_di": "03760244032492", "udi_public": "(01)03760244032492(11)180621", "openfda": { "device_name": "Neurological Stereotaxic Instrument", "medical_specialty_description": "Neurology", "regulation_number": "882.4560", "device_class": "2" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem", "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "TX", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "09/20/2022", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20250729", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "9047", "patient": [ { "patient_sequence_number": "1", "date_received": "20220829", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Intracranial Hemorrhage", "Intracranial Hemorrhage" ] } ], "distributor_city": "", "date_report": "20220920", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "FR", "manufacturer_contact_city": "JACKSONVILLE", "mdr_report_key": "15315047", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20220803", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "34130", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "MEDTECH SAS", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "N", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "298873978", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "ZIMMER BIOMET COMPLAINT (B)(4). COUNTRY OF ORIGIN USA. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED." }, { "mdr_text_key": "298873979", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING AN RNS THE PATIENT RECEIVED A BLOOD TRANSFUSION DUE TO A BLEED. THE TRANSFUSION OCCURRED AFTER THE STEREOTACTIC PORTION AND DURING THE CRANIOTOMY. OTHER THAN THE BLOOD TRANSFUSION THERE WAS NO ADDITIONAL IMPACT REPORTED. NO FURTHER INFORMATION AVAILABLE REGARDING THIS EVENT." }, { "mdr_text_key": "331779446", "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 ACCURACY OF ELECTRODES PLACEMENT WAS CONFIRMED BY ANALYSIS. NO DEVICE MALFUNCTION WAS FOUND THOUGH ANALYSIS. IT SHOWED THAT THE REGISTRATION WAS ACCURATE ALTHOUGH THE VERIFICATION WAS NOT PERFORMED AS RECOMMENDED PER IFU. THE EXAMS MRI T1 AND THE CT FIDUCIALS WERE NOT ALIGNED DUE TO FUSION WAS NOT ADJUSTED BUT THE ELECTRODES POSITIONING AT ENTRY POINT IS NOT IMPACTED FOR BOTH TRAJECTORIES. THE DEVICE PASSED THE PREVIOUS PREVENTIVE MAINTENANCE AND WAS CONFORMING TO SPECIFICATIONS." }, { "mdr_text_key": "331779447", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING AN RNS THE PATIENT RECEIVED A BLOOD TRANSFUSION DUE TO A BLEED. THE TRANSFUSION OCCURRED AFTER THE STEREOTACTIC PORTION AND DURING THE CRANIOTOMY. OTHER THAN THE BLOOD TRANSFUSION THERE WAS NO ADDITIONAL IMPACT REPORTED. NO FURTHER INFORMATION AVAILABLE REGARDING THIS EVENT." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "432 RUE DU RAJOL", "distributor_zip_code": "", "manufacturer_contact_postal_code": "32218", "manufacturer_contact_exchange": "904", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "09/21/2022" } ] }