{ "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": "3009185973-2019-00053", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20190301", "manufacturer_address_2": "", "pma_pmn_number": "K172444", "date_of_event": "20190131", "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": [ "HEALTH PROFESSIONAL" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20190301", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "175748", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20190301", "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": "DRILL BIT ADAPTOR", "catalog_number": "ROSAS00082", "lot_number": "N/A", "other_id_number": "", "device_availability": "No", "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 Jam", "Mechanical Jam" ], "reporter_state_code": "MD", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "04/08/2019", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250811", "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": "20190301", "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": "20190409", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "8382074", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20190131", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Replace" ], "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": "310615000", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT A DRILL BIT GOT STUCK IN A DRILL BIT ADAPTOR. DHR REVIEW AND REVIEW OF COMPLAINT HISTORY DID NOT IDENTIFY ANY CONTRIBUTORY FACTORS TO THE EVENT. ACCORDING TO TECHNICAL INVESTIGATION THE ROOT CAUSE OF THIS EVENT IS A USE ERROR, THE DRILLING METHOD WAS NOT CORRECT. CORRECTED DATA: DATE OF THIS REPORT. DATE RECEIVED BY MANUFACTURER. IF FOLLOW-UP, WHAT TYPE. DEVICE EVALUATED BY MANUFACTURER. EVENT PROBLEM AND EVALUATION CODES." }, { "mdr_text_key": "310615001", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "AT 11:35AM, SURGEON INSERTED DRILL BIT INTO ROSA 2.45MM DRILL ADAPTOR AND NOTED THAT \"BLACK ASH-LIKE MATERIAL\" WAS PUSHED OUT FROM INSIDE THE FIRST ADAPTOR INDICATING INSUFFICIENT STERILIZATION/CLEANING. UNCLEAN ROSA ADAPTOR AND ADTECH DRILL BIT WERE SET ASIDE, AND BACKUPS PREPARED. AT APPROXIMATELY 11:40AM, WHILE SURGICAL FELLOW DRILLED THROUGH SKULL AT TRAJECTORY \"LEFT FRONTAL\" FOR APPROXIMATELY ONE MINUTE, DRILL BIT FUSED IN THE 2.45MM ADAPTOR (MT-02-161 S18411). SURGEON DECIDED TO POSTPONE SURGERY UNTIL THE FOLLOWING MORNING DUE TO CONCERNS REGARDING DURATION OF ANESTHETIZATION. FIELD SERVICE ENGINEER REQUESTED FUSED ADAPTOR FOR FURTHER ANALYSIS, BUT NURSE MANAGER REFUSED. (B)(6) SURGERY WAS COMPLETED SUCCESSFULLY ON (B)(6) 2019." }, { "mdr_text_key": "137536527", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "UDI: (B)(4). THE DEVICE HAS NOT BEEN EVALUATED YET FOR INVESTIGATION PURPOSE. ONCE THE EVALUATION IS PERFORMED, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED." }, { "mdr_text_key": "137536528", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AT 11:35AM, SURGEON INSERTED DRILL BIT INTO ROSA 2.45MM DRILL ADAPTOR AND NOTED THAT \"BLACK ASH-LIKE MATERIAL\" WAS PUSHED OUT FROM INSIDE THE FIRST ADAPTOR INDICATING INSUFFICIENT STERILIZATION/CLEANING. UNCLEAN ROSA ADAPTOR AND ADTECH DRILL BIT WERE SET ASIDE, AND BACKUPS PREPARED. AT APPROXIMATELY 11:40AM, WHILE SURGICAL FELLOW DRILLED THROUGH SKULL AT TRAJECTORY \"LEFT FRONTAL\" FOR APPROXIMATELY ONE MINUTE, DRILL BIT FUSED IN THE 2.45MM ADAPTOR ((B)(4)). SURGEON DECIDED TO POSTPONE SURGERY UNTIL THE FOLLOWING MORNING DUE TO CONCERNS REGARDING DURATION OF ANESTHETIZATION. FIELD SERVICE ENGINEER REQUESTED FUSED ADAPTOR FOR FURTHER ANALYSIS, BUT NURSE MANAGER REFUSED. SEEG SURGERY WAS COMPLETED SUCCESSFULLY ON (B)(6) 2019." } ], "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": "04/10/2019" } ] }