{ "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": "MAUGIO, LANGUEDOC-ROUSSILLON", "manufacturer_contact_address_1": "1520 TRADEPORT DRIVE", "manufacturer_contact_pcity": "90474144", "event_type": "Injury", "report_number": "3009185973-2022-00008", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20220211", "manufacturer_address_2": "", "pma_pmn_number": "K200511", "date_of_event": "20220110", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "32218", "reporter_occupation_code": "OTHER HEALTH CARE PROFESSIONAL", "manufacturer_contact_plocal": "9047414400", "noe_summarized": "1", "manufacturer_contact_l_name": "SHARMA", "source_type": [ "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "34130", "manufacturer_g1_state": "", "reporter_country_code": "FI", "manufacturer_contact_area_code": "904", "date_added": "20220211", "manufacturer_contact_f_name": "JAY", "device_date_of_manufacturer": "20201223", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1119147", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "U", "date_received": "20220211", "brand_name": "ROSA ONE", "generic_name": "COMMON DEVICE NAME:", "manufacturer_d_name": "MEDTECH SAS", "manufacturer_d_address_1": "432 RUE DU RAJOL", "manufacturer_d_address_2": "", "manufacturer_d_city": "MAUGIO, 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": "ROSAS00247", "lot_number": "3.1.5.28", "other_id_number": "", "device_availability": "Yes", "device_report_product_code": "HAW", "device_age_text": "DA", "device_evaluated_by_manufacturer": "R", "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": [ "Incorrect, Inadequate or Imprecise Result or Readings", "Incorrect, Inadequate or Imprecise Result or Readings" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "03/29/2022", "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": "20220211", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding", "Hemorrhage/Blood Loss/Bleeding" ] } ], "distributor_city": "", "date_report": "20220331", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "FR", "manufacturer_contact_city": "JACKSONVILLE", "mdr_report_key": "13514578", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20220114", "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": "328050978", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "A FULL ANALYSIS OF THE DATA LOGS HAS BEEN PERFORMED AND THIS ANALYSIS CONCLUDED THAT AN INACCURACY IS CONFIRMED FOR FOUR TRAJECTORIES AMONG ELEVEN AT THE ENTRY POINT AS THE ERROR IS OVER THE SPECIFICATION LIMIT OF 2 MM MAXIMUM TO 2.79 MM. NO TREND WAS FOUND ABOUT THE AREA AND DIRECTION OF THE DEVIATED ELECTRODES. REGARDING THE FIRST STEPS OF THE PROCEDURE, IT WAS FOUND THAT: THE REGISTRATION VERIFICATION WAS NOT PERFORMED PROPERLY REGARDING TO IFU INSTRUCTIONS, NOTABLY, THE REGISTRATION ACCURACY COULD NOT BE CORRECTLY VERIFIED AND WAS VALIDATED WITH ERRORS, BOTH TIMES. THE PRE-OPERATIVE EXAM FUSION, AS WELL AS THE INTRA-OPERATIVE FUSION AND POST-OPERATIVE FUSION WERE NOT FULLY CORRECT AND WERE NOT PROPERLY ADJUSTED BY THE USER AS RECOMMENDED IN THE IFU. ADDITIONAL QUESTION TO THE USER PERMITTED TO CONFIRM THAT THE MAIN ISSUE WAS A LACK OF EXPERTISE ABOUT THE IMAGE FUSION. ALTHOUGH THE IFU AND THE SOFTWARE CONTAINS ALL NECESSARY WARNINGS, INFORMATION AND TOOLS TO REWORK THE INCORRECT FUSION MANUALLY, AN ISSUE OF THE AUTOMATIC FUSION ALGORITHM PERFORMANCE WAS STILL NOTED AND WILL BE ADDRESSED THROUGH THE CONTINUOUS IMPROVEMENT PROCESS OF OUR PRODUCTS. CORRECTED DATA: B3 DATE OF EVENT B4 DATE OF THIS REPORT G3 DATE RECEIVED BY MANUFACTURER H2 IF FOLLOW-UP, WHAT TYPE H3 DEVICE EVALUATED BY MANUFACTURER H6 ADVERSE EVENT PROBLEM H10 ADDITIONAL NARRATIVES/DATA." }, { "mdr_text_key": "328050979", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "AT THE BEGINNING OF THE PROCEDURE, THE ROBOT REGISTRATION WENT AS USUAL, THE FRAME REGISTRATION ERROR WAS 0.33 MM AND THE ROBOT REGISTRATION ERROR 0.53 MM. AFTER IMPLANTATION OF THE FIFTH ELECTRODE, I FOUND THAT 4/5 OF THE LENGTHS OF THE ELECTRODES HAD A SYSTEMATIC 5 MM ERROR AND WE TOOK AN O-ARC IMAGE, FROM WHICH IT WAS FOUND THAT ALL BUT ONE ELECTRODE (4/5) WERE 5 MM TOO ANTERIOR TO THE PLAN. THE ELECTRODE, WHICH WAS DESIGNED TO BE ORIENTED, WAS TIPPED SLIGHTLY OBLIQUELY TO THE SKULL BONE, THE MISALIGNED ELECTRODES WERE ALL ORIENTED AT AN ANGLE OF ABOUT 90 DEGREES TO THE SKULL BONE. ANATOMICALLY, HOWEVER, WITH THE EXCEPTION OF ONE ELECTRODE, THE OTHER ELECTRODES APPEARED TO BE STILL IN PLACE. IT WAS DECIDED THAT I MADE A NEW REGISTRATION, AFTER WHICH THE ERROR SEEMED TO BE FIXED. IN A POST-OPERATIVE EXAMINATION, BASED ON THE FUSIONS MADE BY THE PHYSICIST, THE ELECTRODES ARE IN PLACE. AT THE END OF THE PROCEDURE, AN ELECTRODE THAT WAS OUTSIDE THE ANATOMICAL AREA WAS REPLACED. WHEN THE SCREW WAS PLACED IN THE NEW POSITION, NEXT TO THE HOLE IN THE FORMER DRILL, THE THREADS OF THE SCREW CRACK THROUGH THE BONE, THE SCREW SANK INTRACRANIALLY ALONG THE EXTERNAL THREADS AND HAD TO BE REMOVED. THE SINKING OF THE SCREW INSIDE THE BONE CAUSED A SMALL LOCAL BLEEDING INTO THE BRAIN TISSUE OF THE PATIENT. DUE TO THE COMPLICATION, THE ELECTRODE IN QUESTION WAS THUS NOT PLACED IN THE PATIENT. THERE WAS NO PATIENT IMPACT CAUSED BY THOSE EVENTS." }, { "mdr_text_key": "285625571", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "AT THE BEGINNING OF THE PROCEDURE, THE ROBOT REGISTRATION WENT AS USUAL, THE FRAME REGISTRATION ERROR WAS 0.33 MM AND THE ROBOT REGISTRATION ERROR 0.53 MM. AFTER IMPLANTATION OF THE FIFTH ELECTRODE, I FOUND THAT 4/5 OF THE LENGTHS OF THE ELECTRODES HAD A SYSTEMATIC 5 MM ERROR AND WE TOOK AN O-ARC IMAGE, FROM WHICH IT WAS FOUND THAT ALL BUT ONE ELECTRODE (4/5) WERE 5 MM TOO ANTERIOR TO THE PLAN. THE ELECTRODE, WHICH WAS DESIGNED TO BE ORIENTED, WAS TIPPED SLIGHTLY OBLIQUELY TO THE SKULL BONE, THE MISALIGNED ELECTRODES WERE ALL ORIENTED AT AN ANGLE OF ABOUT 90 DEGREES TO THE SKULL BONE. ANATOMICALLY, HOWEVER, WITH THE EXCEPTION OF ONE ELECTRODE, THE OTHER ELECTRODES APPEARED TO BE STILL IN PLACE. IT WAS DECIDED THAT I MADE A NEW REGISTRATION, AFTER WHICH THE ERROR SEEMED TO BE FIXED. IN A POST-OPERATIVE EXAMINATION, BASED ON THE FUSIONS MADE BY THE PHYSICIST, THE ELECTRODES ARE IN PLACE. AT THE END OF THE PROCEDURE, AN ELECTRODE THAT WAS OUTSIDE THE ANATOMICAL AREA WAS REPLACED. WHEN THE SCREW WAS PLACED IN THE NEW POSITION, NEXT TO THE HOLE IN THE FORMER DRILL, THE THREADS OF THE SCREW CRACK THROUGH THE BONE, THE SCREW SANK INTRACRANIALLY ALONG THE EXTERNAL THREADS AND HAD TO BE REMOVED. THE SINKING OF THE SCREW INSIDE THE BONE CAUSED A SMALL LOCAL BLEEDING INTO THE BRAIN TISSUE OF THE PATIENT. DUE TO THE COMPLICATION, THE ELECTRODE IN QUESTION WAS THUS NOT PLACED IN THE PATIENT. THERE WAS NO PATIENT IMPACT CAUSED BY THOSE EVENTS." }, { "mdr_text_key": "285625572", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "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# : (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": "03/31/2022" } ] }