{ "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": "3009185973-2019-00108", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20190328", "manufacturer_address_2": "", "pma_pmn_number": "K172444", "date_of_event": "20190301", "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": "20190328", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "253787", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20190328", "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": "HEALTH PROFESSIONAL", "model_number": "ROSAS00084", "catalog_number": "3.2 MM DRILL ADAPTOR", "lot_number": "ROSA3-283A", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20190503", "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": [ "Mechanical Problem", "Mechanical Problem" ], "reporter_state_code": "IN", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "06/21/2019;03/16/2020", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250727", "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": "20190328", "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": "20200317", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "8459770", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20190301", "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": "312135957", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "THE FIELD SERVICE ENGINEER (FSE) WAS PRESENT FOR AN SEEG CASE AT RILEY CHILDREN¿S. THE SURGEON HAD PLANNED 11 TRAJECTORIES. THE SURGEON INSERTS LARGER BOLTS (3.2MM OUTER DIAMETER) FOR HIS SEEG CASES SO THAT HE CAN POTENTIALLY USE THE SAME BOLTS TO TREAT THE PATIENT WITH ABLATION IF NECESSARY. THEREFORE, HE WAS DRILLING WITH THE 3.2MM DRILL ADAPTOR (SERIAL NUMBER (B)(6) ON THE FIRST TRAJECTORY (LISTED AS #4 IN THE PATIENT PLAN) WHEN THE DRILL BIT BECAME LODGED IN THE DRILL ADAPTOR. SINCE THE SITE DOES NOT HAVE A BACKUP 3.2MM ROSA DRILL ADAPTOR, THE SURGEON AND THE OR STAFF REMOVED THE DRILL BIT FROM THE ADAPTOR. THIS REQUIRED SOME EFFORT, AND WATER IRRIGATION AND MINERAL OIL WERE USED TO HELP LUBRICATE THE INSIDE OF THE ADAPTOR. AFTER SUCCESSFULLY REMOVING THE DRILL BIT AND REPLACING IT WITH A NEW ONE, THE SURGEON TESTED WHETHER THE NEW DRILL BIT WAS ABLE TO EASILY SLIDE INTO THE ADAPTOR WITHOUT ANY CATCHING OR PROBLEMS. HE DIDN¿T NOTICE ANY PROBLEMS, AND WANTED TO TRY FINISHING TO DRILL THE HOLE. FSE AND OR TEAM DECIDED IT WOULD BE BEST TO CONTINUALLY IRRIGATE WITH WATER DURING THE DRILL PROCESS TO REMOVE HEAT AND KEEP THE DRILL BIT AND ADAPTOR LUBRICATED. THE SURGEON WAS THEN ABLE TO COMPLETE ALL 11 TRAJECTORIES WITHOUT ANY OTHER INCIDENT. THE SURGEON WOULD LIKE TO KEEP THE 3.2MM DRILL ADAPTOR USED DURING THIS CASE UNTIL THE REPLACEMENT ARRIVES, SINCE HE WAS ABLE TO FINISH THE CASEWITHOUT ISSUES." }, { "mdr_text_key": "312135958", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT THE DRILL BIT LODGED IN THE DRILL ADAPTOR. A DHR REVIEW AND A COMPLAINT HISTORY REVIEW WERE PERFORMED AND DID NOT IDENTIFY ANY CONTRIBUTORY FACTORS TO THE EVENT. PRODUCT WAS RETURNED AND VISUAL INSPECTION CONFIRMED THE DAMAGE OF THE DRILL ADAPTOR. HOWEVER THE ROOT CAUSE OF ITS DAMAGES REMAINS UNKNOWN. (B)(4)." }, { "mdr_text_key": "318000038", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "THE FIELD SERVICE ENGINEER (FSE) WAS PRESENT FOR AN SEEG CASE AT RILEY CHILDREN¿S. THE SURGEON HAD PLANNED 11 TRAJECTORIES. THE SURGEON INSERTS LARGER BOLTS (3.2MM OUTER DIAMETER) FOR HIS SEEG CASES SO THAT HE CAN POTENTIALLY USE THE SAME BOLTS TO TREAT THE PATIENT WITH ABLATION IF NECESSARY. THEREFORE, HE WAS DRILLING WITH THE 3.2MM DRILL ADAPTOR (SERIAL NUMBER (B)(6) ) ON THE FIRST TRAJECTORY (LISTED AS #4 IN THE PATIENT PLAN) WHEN THE DRILL BIT BECAME LODGED IN THE DRILL ADAPTOR. SINCE THE SITE DOES NOT HAVE A BACKUP 3.2MM ROSA DRILL ADAPTOR, THE SURGEON AND THE OR STAFF REMOVED THE DRILL BIT FROM THE ADAPTOR. THIS REQUIRED SOME EFFORT, AND WATER IRRIGATION AND MINERAL OIL WERE USED TO HELP LUBRICATE THE INSIDE OF THE ADAPTOR. AFTER SUCCESSFULLY REMOVING THE DRILL BIT AND REPLACING IT WITH A NEW ONE, THE SURGEON TESTED WHETHER THE NEW DRILL BIT WAS ABLE TO EASILY SLIDE INTO THE ADAPTOR WITHOUT ANY CATCHING OR PROBLEMS. HE DIDN¿T NOTICE ANY PROBLEMS, AND WANTED TO TRY FINISHING TO DRILL THE HOLE. FSE AND OR TEAM DECIDED IT WOULD BE BEST TO CONTINUALLY IRRIGATE WITH WATER DURING THE DRILL PROCESS TO REMOVE HEAT AND KEEP THE DRILL BIT AND ADAPTOR LUBRICATED. THE SURGEON WAS THEN ABLE TO COMPLETE ALL 11 TRAJECTORIES WITHOUT ANY OTHER INCIDENT. THE SURGEON WOULD LIKE TO KEEP THE 3.2MM DRILL ADAPTOR USED DURING THIS CASE UNTIL THE REPLACEMENT ARRIVES, SINCE HE WAS ABLE TO FINISH THE CASE WITHOUT ISSUES." }, { "mdr_text_key": "318000039", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "CORRECTED DATA: B1 REPORT TYPE, B2 OUTCOMES ATTRIBUTED TO ADVERSE EVENT, B4 DATE OF THIS REPORT, G4 DATE RECEIVED BY MANUFACTURER, AND H2 IF FOLLOW-UP, WHAT TYPE." }, { "mdr_text_key": "140164149", "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)." }, { "mdr_text_key": "140164150", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THE FIELD SERVICE ENGINEER (FSE) WAS PRESENT FOR AN (B)(6) . THE SURGEON HAD PLANNED 11 TRAJECTORIES. THE SURGEON INSERTS LARGER BOLTS (3.2MM OUTER DIAMETER) FOR HIS SEEG CASES SO THAT HE CAN POTENTIALLY USE THE SAME BOLTS TO TREAT THE PATIENT WITH ABLATION IF NECESSARY. THEREFORE, HE WAS DRILLING WITH THE 3.2MM DRILL ADAPTOR (SERIAL NUMBER (B)(4)) ON THE FIRST TRAJECTORY (LISTED AS #4 IN THE PATIENT PLAN) WHEN THE DRILL BIT BECAME LODGED IN THE DRILL ADAPTOR. SINCE THE SITE DOES NOT HAVE A BACKUP 3.2MM ROSA DRILL ADAPTOR, THE SURGEON AND THE OR STAFF REMOVED THE DRILL BIT FROM THE ADAPTOR. THIS REQUIRED SOME EFFORT, AND WATER IRRIGATION AND MINERAL OIL WERE USED TO HELP LUBRICATE THE INSIDE OF THE ADAPTOR. AFTER SUCCESSFULLY REMOVING THE DRILL BIT AND REPLACING IT WITH A NEW ONE, THE SURGEON TESTED WHETHER THE NEW DRILL BIT WAS ABLE TO EASILY SLIDE INTO THE ADAPTOR WITHOUT ANY CATCHING OR PROBLEMS. HE DIDN¿T NOTICE ANY PROBLEMS, AND WANTED TO TRY FINISHING TO DRILL THE HOLE. FSE AND OR TEAM DECIDED IT WOULD BE BEST TO CONTINUALLY IRRIGATE WITH WATER DURING THE DRILL PROCESS TO REMOVE HEAT AND KEEP THE DRILL BIT AND ADAPTOR LUBRICATED. THE SURGEON WAS THEN ABLE TO COMPLETE ALL 11 TRAJECTORIES WITHOUT ANY OTHER INCIDENT. THE SURGEON WOULD LIKE TO KEEP THE 3.2MM DRILL ADAPTOR USED DURING THIS CASE UNTIL THE REPLACEMENT ARRIVES, SINCE HE WAS ABLE TO FINISH THE CASE WITHOUT ISSUES." } ], "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": "07/18/2019;03/17/2020" } ] }