{ "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": "900 RUE DU MAS DE VERCHANT", "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": "3009185973-2021-00182", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20211129", "manufacturer_address_2": "", "pma_pmn_number": "K200511", "date_of_event": "20211027", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "32218", "reporter_occupation_code": "BIOMEDICAL ENGINEER", "manufacturer_contact_plocal": "9047414400", "noe_summarized": "1", "manufacturer_contact_l_name": "SHARMA", "source_type": [ "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": "20211129", "manufacturer_contact_f_name": "JAY", "device_date_of_manufacturer": "20210415", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1784547", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "U", "date_received": "20211129", "brand_name": "ROSA ONE BRAIN + SPINE", "generic_name": "ROSA ONE", "manufacturer_d_name": "MEDTECH SAS", "manufacturer_d_address_1": "432 RUE DU RAJOL", "manufacturer_d_address_2": "900 RUE DU MAS DE VERCHANT", "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": "ROSA ONE 3.1", "catalog_number": "ROSAS00203", "lot_number": "3.1.4.1652", "other_id_number": "", "device_availability": "Yes", "device_report_product_code": "HAW", "device_age_text": "DA", "device_evaluated_by_manufacturer": "Y", "combination_product_flag": "N", "udi_di": "03760244033765", "udi_public": "(01)03760244033765", "openfda": { "device_name": "Neurological Stereotaxic Instrument", "medical_specialty_description": "Neurology", "regulation_number": "882.4560", "device_class": "2" } } ], "product_problems": [ "Computer Software Problem", "Incorrect, Inadequate or Imprecise Result or Readings", "Computer Software Problem", "Incorrect, Inadequate or Imprecise Result or Readings" ], "reporter_state_code": "TX", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "04/26/2022", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20250807", "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": "20211129", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hematoma", "Hematoma" ] } ], "distributor_city": "", "date_report": "20220426", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "FR", "manufacturer_contact_city": "JACKSONVILLE", "mdr_report_key": "12882859", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20211027", "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": "328981048", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "A FULL ANALYSIS OF THE DATA LOGS HAS BEEN PERFORMED AND CONCLUDED THAT AN INACCURACY OF 3.5MM TO 4.5MM IS CONFIRMED FOR THE FIRST SIX TRAJECTORIES IMPLANTED. THE CONTACTLESS REGISTRATION WAS PERFORMED CORRECTLY, ALTHOUGH NO ENTRY POINT WAS VERIFIED WITH THE DISTANCE SENSOR BEFORE GOING TO GUIDANCE WHICH IS RECOMMENDED IN THE INSTRUCTIONS FOR USE. THE FUSION BETWEEN THE PRE-OPERATIVE MRI AND CT EXAMS SHOWED A SMALL SHIFT, BUT THIS COULD NOT EXPLAIN THE ELECTRODE PLACEMENT INACCURACY. THE INACCURACY OF THE SIX ELECTRODES COULD BE DUE TO AN UNDETECTED MOVEMENT OF THE HEAD FOLLOWING THE REGISTRATION. THEN, A SECOND REGISTRATION WAS PERFORMED WITH THE POINTER PROBE. THE REGISTRATION ACCURACY WAS NOT CORRECTLY VERIFIED AND MARKERS WERE INCORRECTLY PLACED. RECOMMENDED PLACEMENT OF MARKERS IS WRITTEN IN THE INSTRUCTIONS FOR USE. AFTER THIS REGISTRATION, THE OTHER FIVE TRAJECTORIES WERE IMPLANTED. THESE TRAJECTORIES SEEM TO BE ACCURATE, ALTHOUGH THIS COULD NOT BE CONFIRMED BECAUSE THE POST-OPERATIVE SCAN WAS NOT PROVIDED FOR ANALYSIS. ANALYSIS SHOWS NO MALFUNCTION OF THE DEVICE." }, { "mdr_text_key": "328981049", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "ZIMMER BIOMET MEDTECH HAS BEEN MADE AWARE OF A SERIOUS ADVERSE EVENT THAT OCCURRED AT THE HOUSTON VA, IN WITH ROBOT S/N (B)(6). A SYSTEMATIC REGISTRATION ERROR APPEARED TO BE PRESENT WITH AN INTRAOPERATIVE O-ARM SPIN. THE DAY OF THESE CASE, WEDNESDAY (B)(6), AN INACCURACY OCCURRED. ON THE FOLLOWING DAY, THE (B)(6), THE PATIENT HAD AN INTRAPARENCHYMAL HEMATOMA OF ABOUT 2 CM IN SIZE. THE PATIENT IS ANTICIPATED TO MAKE A FULL RECOVERY." }, { "mdr_text_key": "281334567", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "ZIMMER BIOMET MEDTECH HAS BEEN MADE AWARE OF A SERIOUS ADVERSE EVENT THAT OCCURRED AT THE (B)(6), IN WITH ROBOT S/N (B)(4). A SYSTEMATIC REGISTRATION ERROR APPEARED TO BE PRESENT WITH AN INTRAOPERATIVE O-ARM SPIN. THE DAY OF THESE CASE, WEDNESDAY 27TH OF OCTOBER, AN INACCURACY OCCURRED. ON THE FOLLOWING DAY, THE 28TH, THE PATIENT HAD AN INTRAPARENCHYMAL HEMATOMA OF ABOUT 2 CM IN SIZE. THE PATIENT IS ANTICIPATED TO MAKE A FULL RECOVERY." }, { "mdr_text_key": "281334568", "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. THE PRELIMINARY ANALYSIS OF SOFTWARE LOGS AND PATIENT FILES REVEALED THAT THE CONTACTLESS REGISTRATION WAS PERFORMED CORRECTLY BEFORE SURGERY, ALTHOUGH NO ENTRY POINT WAS VERIFIED WITH THE DISTANCE SENSOR BEFORE GOING TO GUIDANCE. THE FUSION SHOWS NO ISSUE. AN INACCURACY OF 3.5MM TO 4.5MM IS CONFIRMED FOR THE FIRST SIX TRAJECTORIES IMPLANTED. THEN, A SECOND REGISTRATION WAS PERFORMED WITH THE POINTER PROBE. AFTER THIS REGISTRATION, THE OTHER FIVE TRAJECTORIES WERE IMPLANTED. THESE TRAJECTORIES SEEM TO BE ACCURATE, ALTHOUGH THIS COULD NOT BE CONFIRMED BECAUSE THE POST-OPERATIVE SCAN SHOWING THESE TRAJECTORIES WAS NOT PROVIDED FOR ANALYSIS. AT THIS POINT, OUR ANALYSIS SHOWS NO MALFUNCTION OF THE DEVICE. MEDICAL DEVICE: UDI#: (B)(4)." } ], "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": "04/29/2022" } ] }