{ "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": "3009185973-2020-00260", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20201009", "manufacturer_address_2": "", "pma_pmn_number": "K200511", "date_of_event": "20201002", "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": "20201009", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1121609", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20201009", "brand_name": "ROSA ONE", "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 ONE", "catalog_number": "ROSAS00203", "lot_number": "3.1.4.1650", "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": [ "Malposition of Device", "Malposition of Device" ], "reporter_state_code": "MO", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "01/15/2021", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250810", "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": "20201009", "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": "20210118", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10654601", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20201002", "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": "322652129", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "A DETAILED ANALYSIS OF THE DATA LOGS HAS BEEN PERFORMED. THIS ANALYSIS CONCLUDED THAT NO FAILURE OF THE ROSA DEVICE WAS DETECTED, AND OUR MEASUREMENTS SUGGEST THAT THE TRAJECTORY WAS ACCURATE. THE INACCURACY DETECTED BY THE USER ON THE POSTOP MRI MIGHT BE DUE TO THE INCORRECT MERGE OF THE O-ARM SCAN WITH THE PREOPERATIVE MRI. BASED ON THE INVESTIGATION PERFORMED, THE TECHNICAL ROOT CAUSE OF THE EVENT WAS DETERMINED TO BE RELATED TO A USE ERROR (MANUAL ADJUSTMENTS OF THE FUSION NOT PERFORMED)." }, { "mdr_text_key": "322652130", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "COMPANY CLINICAL REPRESENTIVE (CR) WAS PRESENT FOR A MONTERIS ABLATION CASE. THE SURGEON PLANNED ONE TRAJECTORY FOR A FAIRLY SUPERFICIAL LESION IN THE PARIETAL LOBE. FIDUCIAL REGISTRATION WAS PERFORMED BY GETTING AN O-ARM SCAN AND MERGING IT TO THE PREOPERATIVE MRI. BOTH SURGEON AND CR LOOKED AT THE MERGE AND CONFIRMED ACCURACY. AFTER PLACING THE TRAJECTORY, THE PATIENT WAS DETACHED FROM ROSA AND THE MRI MACHINE WAS BROUGHT IN TO BEGIN THE ABLATION. WHEN THE FIRST INTRAOPERATIVE MRI WAS TAKEN, HOWEVER, IT SHOWED THAT THE TRAJECTORY WAS SEVERAL MILLIMETERS INFERIOR THAN THE PLANNING TARGET POINT. AS A RESULT, SURGEON WAS NOT ABLE TO ABLATE AS MUCH AS THE LESION AS HE WANTED. SURGEON AND CR AGAIN LOOKED AT THE MERGE BETWEEN THE O-ARM SCAN AND THE PREOPERATIVE MRI AND DID NOT BELIEVE THAT THE MERGE COULD HAVE CAUSED THE INACCURACY. SURGEON DID NOT NOTICE ANY HEAD SHIFT, THE TRAJECTORY DID NOT SEEM TO SKIVE DURING DRILLING OR BOLT PLACEMENT, AND THE FIDUCIAL REGISTRATION GAVE A GOOD RMS VALUE THAT BOTH THE CR AND SURGEON FOUND ACCEPTABLE. THE INTRAOPERATIVE MRI SCAN SHOWING THE PLACEMENT OF THE FIBER WOULD NOT MERGE CORRECTLY TO THE PREOPERATIVE MRI, BUT THE CR RETRIEVED IT FOR THE CHT TEAM TO TRY TO MERGE INTO THE PLAN THEMSELVES. NO KNOWN IMPACT TO PATIENT, ERROR OCCURRED AFTER FIRST INCISION AND PATIENT WAS ALREADY UNDER ANESTHESIA, NO DELAY TO CASE. THE SURGEON WILL NOT REPERFORM THE SURGERY AND THERE WAS NO PATIENT IMPACT OR CHANGE." }, { "mdr_text_key": "210657893", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE DEVICE HAS NOT BEEN EVALUATED YET FOR INVESTIGATION PURPOSE. ONCE THE EVALUATION IS PERFORMED, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED. UDI # (UNIQUE IDENTIFIER (UDI) #: (B)(4)." }, { "mdr_text_key": "210657894", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "COMPANY CLINICAL REPRESENTATIVE (CR) WAS PRESENT FOR A MONTERIS ABLATION CASE. THE SURGEON PLANNED ONE TRAJECTORY FOR A FAIRLY SUPERFICIAL LESION IN THE PARIETAL LOBE. FIDUCIAL REGISTRATION WAS PERFORMED BY GETTING AN O-ARM SCAN AND MERGING IT TO THE PREOPERATIVE MRI. BOTH SURGEON AND CR LOOKED AT THE MERGE AND CONFIRMED ACCURACY. AFTER PLACING THE TRAJECTORY, THE PATIENT WAS DETACHED FROM ROSA AND THE MRI MACHINE WAS BROUGHT IN TO BEGIN THE ABLATION. WHEN THE FIRST INTRAOPERATIVE MRI WAS TAKEN, HOWEVER, IT SHOWED THAT THE TRAJECTORY WAS SEVERAL MILLIMETERS INFERIOR THAN THE PLANNING TARGET POINT. AS A RESULT, SURGEON WAS NOT ABLE TO ABLATE AS MUCH AS THE LESION AS HE WANTED. SURGEON AND CR AGAIN LOOKED AT THE MERGE BETWEEN THE O-ARM SCAN AND THE PREOPERATIVE MRI AND DID NOT BELIEVE THAT THE MERGE COULD HAVE CAUSED THE INACCURACY. SURGEON DID NOT NOTICE ANY HEAD SHIFT, THE TRAJECTORY DID NOT SEEM TO SKIVE DURING DRILLING OR BOLT PLACEMENT, AND THE FIDUCIAL REGISTRATION GAVE A GOOD RMS VALUE THAT BOTH THE CR AND SURGEON FOUND ACCEPTABLE. THE INTRAOPERATIVE MRI SCAN SHOWING THE PLACEMENT OF THE FIBER WOULD NOT MERGE CORRECTLY TO THE PREOPERATIVE MRI, BUT THE CR RETRIEVED IT FOR THE CHT TEAM TO TRY TO MERGE INTO THE PLAN THEMSELVES. NO KNOWN IMPACT TO PATIENT, ERROR OCCURRED AFTER FIRST INCISION AND PATIENT WAS ALREADY UNDER ANESTHESIA, NO DELAY TO CASE." } ], "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": "01/19/2021" } ] }