{ "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": "3009185973-2019-00267", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20190807", "manufacturer_address_2": "", "pma_pmn_number": "K172444", "date_of_event": "20190710", "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": "20190807", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "664207", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20190807", "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": "0", "model_number": "ROSA BRAIN", "catalog_number": "N/A", "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": [ "Display or Visual Feedback Problem", "Imprecision", "Display or Visual Feedback Problem", "Imprecision" ], "reporter_state_code": "CA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/31/2019;08/30/2019", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250731", "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": "20190807", "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": "20190927", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "8868915", "removal_correction_number": "300918597308282019001C", "number_devices_in_event": "", "date_manufacturer_received": "20190710", "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": "312105545", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "CONTACTLESS LASER REGISTRATION WAS UTILIZED WITH THE PATIENT. THE EVENT OCCURRED DURING THE GUIDANCE PORTION OF SURGERY. THE ROSA ARM WAS SENT TO THE FIRST TRAJECTORY. THE ROSA COMPLETE ITS MOVEMENT FURTHER AWAY FROM THE PATIENT THAN NORMALLY OBSERVED. THE SURGEON PROCEEDED TO DO THE USUAL SURGICAL TECHNIQUE TO PLACE IN THE ANCHOR BOLT. WHEN THE SURGEON WAS READY FOR THE DISTANCE TO TARGET MEASUREMENT TO BE TAKEN, THE FIELD SERVICE ENGINEER (FSE) HIT THE DISTANCE TO TARGET BUTTON ON THE ROSA MONITOR BUT NO MEASUREMENT APPEARED ON THE SCREEN. THE FSE ASKED THE SURGEON TO MOVE THE ROSA ARM BACKWARDS AXIALLY AND APPROACH THE ANCHOR BOLT AGAIN SO HE COULD RETRY THE DISTANCE TO TARGET MEASUREMENT. AFTER THE PREVIOUS STEP, STILL NO MEASUREMENT SHOWED UP ON THE SCREEN. THE FSE DECIDED TO HAVE THE ROSA ARM CLEARED AWAY FROM THE PATIENT¿S HEAD, MOVED TO HOME AND THEN HAVE THE ROSA ARM BE DRIVEN BACK ON THE SAME TRAJECTORY AS LAST TIME. THE ROSA ARM ONCE AGAIN STOPPED FROM A FURTHER DISTANCE AWAY FROM THE PATIENT¿S HEAD THAN COMMONLY OBSERVED. THE FSE PUT THE COOPERATIVE MODE TO AXIAL AND SLOW. THE VIGILANCE DEVICE PEDAL WAS PRESSED AND THE SURGEON PUT PRESSURE ON THE DRILL ADAPTOR TO DRIVE IT CLOSER TO THE PATIENT¿S HEAD. AN ERROR SCREEN THEN POPPED UP AND THE ROSA ROBOT PROCEEDED TO SHUT DOWN. THIS SHUTDOWN OCCURRED APPROXIMATELY AT 1:52 PM. THE ROSA HAD TO BE REBOOTED AND THIS REBOOT PROCESS TOOK APPROXIMATELY 5 MINUTES. THE ROSA ARM WAS DRIVEN TO THE SAME SPOT IN AN ATTEMPT TO GET THE DISTANCE TO TARGET MEASUREMENT AGAIN. HOWEVER, THE ALIGNMENT OF THE DRILL ADAPTOR POSITIONING DOES NOT MATCH WITH THE ORIGINALLY PLACED ANCHOR BOLT. THE SURGEON WAS CONCERNED ABOUT WHY THIS ALIGNMENT DOES NOT MATCH UP ANYMORE WITH THE ORIGINAL ANCHOR BOLT PLACEMENT. THE SURGEON DECIDED TO REMOVE THE ANCHOR BOLT AND BREAK DOWN THE STERILE DRAPES, SO HE COULD REREGISTER WITH THE CONTACTLESS LASER. AFTER COMPLETING THE REGISTRATION PROCESS AND BEING SATISFIED WITH THE RESULTS, THE SURGEON HAD THE ROSA PROCEED TO THE TRAJECTORY GUIDANCE MODE. THE ROSA ROBOT CONTINUED SMOOTHLY SINCE THIS SECOND CONTACTLESS REGISTRATION PROCESS AND 20 ELECTRODES WERE PLACED." }, { "mdr_text_key": "312105546", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS REPORT IS PROVIDED TO CORRECT THE UDI NUMBER PROVIDED IN SECTION H10 OF THE INITIAL REPORT. (B)(4)." }, { "mdr_text_key": "312108817", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A SURGERY, IT WAS IMPOSSIBLE TO DISPLAY THE DISTANCE TO TARGET AND THAT A COMMUNICATION FAILURE OCCURRED. THEN, IT WAS NOTICED THAT THE BOLT WAS IMPLANTED INACCURATELY. DHR REVIEW AND REVIEW OF COMPLAINT HISTORY DID NOT IDENTIFY ANY CONTRIBUTORY FACTORS TO THE EVENT. ACCORDING TO TECHNICAL INVESTIGATION THE ANCHOR BOLT WAS PLACED AROUND 16 MM AWAY FROM THE PLAN BECAUSE THE INSTRUMENT HOLDER WAS SEND ON TRAJECTORY WITH THE DISTANCE SENSOR CONFIGURATION. A SPECIFIC WORKFLOW LED TO THIS ERROR AND THIS SOFTWARE ANOMALY IS KNOWN UNDER DESIGN DEFECT REFERENCE BR-120. FOR THE SAME REASON, THE ROBOT DID NOT DETECT THE INSTRUMENT HOLDER INSTALLATION AND FAILED TO GET THE DISTANCE TO TARGET SINCE THIS FUNCTION IS NOT AVAILABLE WITH THE DISTANCE SENSOR IN GUIDANCE. REPORTEDLY, THE USER CONSIDERED THAT THE ERROR MIGHT BE DUE TO A SKIN SHIFT. SIGNIFICANT ERRORS OBSERVED ON THE ENTRY POINT ¿ I.E. >> 2MM SPECIFICATION LIMIT ¿ SHOULD BE CONSIDERED ABNORMAL AND CANNOT REASONABLY BE ATTRIBUTED TO SKIN MOVEMENTS. THIS DESIGN DEFECT WAS ESCALATED THROUGH AN ISSUE EVALUATION, A CAPA AND AN HEALTH AND HAZARD EVALUATION DETERMINATION (HHED). THE FIELD ACTION ZFA-2019-00253 - 3009185973-08-28-2019-001-C IS CURRENTLY OPENED TO PREVENT THIS DESIGN DEFECT TO REOCCUR. THE ROOT CAUSE OF THE COMMUNICATION FAILURE IS A SHARED MEMORY ERROR BETWEEN ROSANNA AND MARIO. SHARED MEMORY ERRORS ARE CURRENTLY BEING ESCALATED AS PART OF THE SCOPE OF A CORRECTIVE ACTION." }, { "mdr_text_key": "312108818", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "CONTACTLESS LASER REGISTRATION WAS UTILIZED WITH THE PATIENT. THE EVENT OCCURRED DURING THE GUIDANCE PORTION OF SURGERY. THE ROSA ARM WAS SENT TO THE FIRST TRAJECTORY. THE ROSA COMPLETE ITS MOVEMENT FURTHER AWAY FROM THE PATIENT THAN NORMALLY OBSERVED. THE SURGEON PROCEEDED TO DO THE USUAL SURGICAL TECHNIQUE TO PLACE IN THE ANCHOR BOLT. WHEN THE SURGEON WAS READY FOR THE DISTANCE TO TARGET MEASUREMENT TO BE TAKEN, THE FIELD SERVICE ENGINEER (FSE) HIT THE DISTANCE TO TARGET BUTTON ON THE ROSA MONITOR BUT NO MEASUREMENT APPEARED ON THE SCREEN. THE FSE ASKED THE SURGEON TO MOVE THE ROSA ARM BACKWARDS AXIALLY AND APPROACH THE ANCHOR BOLT AGAIN SO HE COULD RETRY THE DISTANCE TO TARGET MEASUREMENT. AFTER THE PREVIOUS STEP, STILL NO MEASUREMENT SHOWED UP ON THE SCREEN. THE FSE DECIDED TO HAVE THE ROSA ARM CLEARED AWAY FROM THE PATIENT¿S HEAD, MOVED TO HOME AND THEN HAVE THE ROSA ARM BE DRIVEN BACK ON THE SAME TRAJECTORY AS LAST TIME. THE ROSA ARM ONCE AGAIN STOPPED FROM A FURTHER DISTANCE AWAY FROM THE PATIENT¿S HEAD THAN COMMONLY OBSERVED. THE FSE PUT THE COOPERATIVE MODE TO AXIAL AND SLOW. THE VIGILANCE DEVICE PEDAL WAS PRESSED AND THE SURGEON PUT PRESSURE ON THE DRILL ADAPTOR TO DRIVE IT CLOSER TO THE PATIENT¿S HEAD. AN ERROR SCREEN THEN POPPED UP AND THE ROSA ROBOT PROCEEDED TO SHUT DOWN. THIS SHUTDOWN OCCURRED APPROXIMATELY AT 1:52 PM. THE ROSA HAD TO BE REBOOTED AND THIS REBOOT PROCESS TOOK APPROXIMATELY 5 MINUTES. THE ROSA ARM WAS DRIVEN TO THE SAME SPOT IN AN ATTEMPT TO GET THE DISTANCE TO TARGET MEASUREMENT AGAIN. HOWEVER, THE ALIGNMENT OF THE DRILL ADAPTOR POSITIONING DOES NOT MATCH WITH THE ORIGINALLY PLACED ANCHOR BOLT. THE SURGEON WAS CONCERNED ABOUT WHY THIS ALIGNMENT DOES NOT MATCH UP ANYMORE WITH THE ORIGINAL ANCHOR BOLT PLACEMENT. THE SURGEON DECIDED TO REMOVE THE ANCHOR BOLT AND BREAK DOWN THE STERILE DRAPES, SO HE COULD REREGISTER WITH THE CONTACTLESS LASER. AFTER COMPLETING THE REGISTRATION PROCESS AND BEING SATISFIED WITH THE RESULTS, THE SURGEON HAD THE ROSA PROCEED TO THE TRAJECTORY GUIDANCE MODE. THE ROSA ROBOT CONTINUED SMOOTHLY SINCE THIS SECOND CONTACTLESS REGISTRATION PROCESS AND 20 ELECTRODES WERE PLACED." }, { "mdr_text_key": "153517371", "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.  (B)(4). NO CODE AVAILABLE WAS CHOSEN BECAUSE A DELAY SUPERIOR TO 30 MINUTES OCCURRED AND BECAUSE THE SURGEON DECIDED TO REMOVE THE ANCHOR BOLT. UDI# : (B)(4)." }, { "mdr_text_key": "153517372", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "CONTACTLESS LASER REGISTRATION WAS UTILIZED WITH THE PATIENT. THE EVENT OCCURRED DURING THE GUIDANCE PORTION OF SURGERY. THE ROSA ARM WAS SENT TO THE FIRST TRAJECTORY. THE ROSA COMPLETE ITS MOVEMENT FURTHER AWAY FROM THE PATIENT THAN NORMALLY OBSERVED. THE SURGEON PROCEEDED TO DO THE USUAL SURGICAL TECHNIQUE TO PLACE IN THE ANCHOR BOLT. WHEN THE SURGEON WAS READY FOR THE DISTANCE TO TARGET MEASUREMENT TO BE TAKEN, THE FIELD SERVICE ENGINEER (FSE) HIT THE DISTANCE TO TARGET BUTTON ON THE ROSA MONITOR BUT NO MEASUREMENT APPEARED ON THE SCREEN. THE FSE ASKED THE SURGEON TO MOVE THE ROSA ARM BACKWARDS AXIALLY AND APPROACH THE ANCHOR BOLT AGAIN SO HE COULD RETRY THE DISTANCE TO TARGET MEASUREMENT. AFTER THE PREVIOUS STEP, STILL NO MEASUREMENT SHOWED UP ON THE SCREEN. THE FSE DECIDED TO HAVE THE ROSA ARM CLEARED AWAY FROM THE PATIENT¿S HEAD, MOVED TO HOME AND THEN HAVE THE ROSA ARM BE DRIVEN BACK ON THE SAME TRAJECTORY AS LAST TIME. THE ROSA ARM ONCE AGAIN STOPPED FROM A FURTHER DISTANCE AWAY FROM THE PATIENT¿S HEAD THAN COMMONLY OBSERVED. THE FSE PUT THE COOPERATIVE MODE TO AXIAL AND SLOW. THE VIGILANCE DEVICE PEDAL WAS PRESSED AND THE SURGEON PUT PRESSURE ON THE DRILL ADAPTOR TO DRIVE IT CLOSER TO THE PATIENT¿S HEAD. AN ERROR SCREEN THEN POPPED UP AND THE ROSA ROBOT PROCEEDED TO SHUT DOWN. THIS SHUTDOWN OCCURRED APPROXIMATELY AT 1:52 PM. THE ROSA HAD TO BE REBOOTED AND THIS REBOOT PROCESS TOOK APPROXIMATELY 5 MINUTES. THE ROSA ARM WAS DRIVEN TO THE SAME SPOT IN AN ATTEMPT TO GET THE DISTANCE TO TARGET MEASUREMENT AGAIN. HOWEVER, THE ALIGNMENT OF THE DRILL ADAPTOR POSITIONING DOES NOT MATCH WITH THE ORIGINALLY PLACED ANCHOR BOLT. THE SURGEON WAS CONCERNED ABOUT WHY THIS ALIGNMENT DOES NOT MATCH UP ANYMORE WITH THE ORIGINAL ANCHOR BOLT PLACEMENT. THE SURGEON DECIDED TO REMOVE THE ANCHOR BOLT AND BREAK DOWN THE STERILE DRAPES, SO HE COULD REREGISTER WITH THE CONTACTLESS LASER. AFTER COMPLETING THE REGISTRATION PROCESS AND BEING SATISFIED WITH THE RESULTS, THE SURGEON HAD THE ROSA PROCEED TO THE TRAJECTORY GUIDANCE MODE. THE ROSA ROBOT CONTINUED SMOOTHLY SINCE THIS SECOND CONTACTLESS REGISTRATION PROCESS AND 20 ELECTRODES WERE PLACED." } ], "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": "08/29/2019;09/27/2019" } ] }