{ "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": "2026-08-05", "results": { "skip": 0, "limit": 1, "total": 65 } }, "results": [ { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "", "report_to_fda": "", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "N", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "MW5106062", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20211214", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20210819", "reprocessed_and_reused_flag": "", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "PATIENT", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20211217", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1898144", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20211214", "brand_name": "CONE BEAM CT", "generic_name": "SYSTEM, X-RAY, EXTRAORAL SOURCE, DIGITAL", "manufacturer_d_name": "TROPHY", "manufacturer_d_address_1": "", "manufacturer_d_address_2": "", "manufacturer_d_city": "", "manufacturer_d_state": "", "manufacturer_d_zip_code": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "MUH", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "System, X-Ray, Extraoral Source, Digital", "medical_specialty_description": "Dental", "regulation_number": "872.1800", "device_class": "2" } } ], "product_problems": [ "Labelling, Instructions for Use or Training Problem", "Patient-Device Incompatibility" ], "reporter_state_code": "AZ", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250818", "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": "20211214", "sequence_number_treatment": [ "CANCER DRUGS", " CORTISONE", " MAGNESIUM", " MANY OTHERS BECAUSE OF THE LEUKEMIA", " STOOL SOFTENERS" ], "sequence_number_outcome": [ "Required Intervention", " O", " S", " L", " H" ], "patient_age": "33 YR", "patient_sex": "Female", "patient_weight": "54 KG", "patient_ethnicity": "Non Hispanic", "patient_race": "White", "patient_problems": [ "Cancer", "Cancer" ] } ], "distributor_city": "", "date_report": "20211211", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "13011772", "removal_correction_number": "", "number_devices_in_event": "", "manufacturer_name": "", "report_source_code": "Voluntary 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": "282389551", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "DURING THE YEARS FROM 2001 TO 2006 OUR DAUGHTER RECEIVED SEVERAL CONE BEAM CT'S AS PART OF HER ORTHODONTIC TREATMENT. WE WERE TOLD THIS WAS OBLIGATORY TO GET BRACES. THE DENTIST, (B)(6), WROTE THE PRESCRIPTIONS. HE NEVER DISCUSSED THE POSSIBILITY OF LEUKEMIA OR BRAIN CANCER DEVELOPING AS A RESULT. OUR DAUGHTER WAS AGED (B)(6) DURING THE YEARS OF 2001 TO 2005 WHEN MOST OF THIS WAS DONE. THIS PAST (B)(6) OF 2021, OUR (B)(6) DAUGHTER WAS DIAGNOSED WITH ACUTE MYELOID LEUKEMIA. OUR DAUGHTER WAS A FULL TERM BABY WITH NO PROBLEMS. HER MOTHER WAS NEVER EXPOSED TO ANYTHING. NONE OF US EVER SMOKED, TOOK ALCOHOL, OR TOOK DRUGS. OUR DAUGHTER WORKED AS AN ELEMENTARY TEACHER FOR 9 YEARS AND HAD A BABY 17 MONTHS AGO. OUR DAUGHTER, (B)(6), NEVER HAD ANY PRIOR X-RAYS OTHER THAN THE CONE BEAM CT'S. SHE HAD A FEW BITE WING X-RAYS DONE OVER THE YEARS AND MAYBE A PANEL WHEN SHE WAS AN ADULT. WE LIVED IN A CLEAN NEIGHBORHOOD WITH NO EXPOSURE TO CHEMICALS, WIRES, OR OTHER ENVIRONMENTAL HAZARDS. AFTER DOING A LOT OF RESEARCH ON CONE BEAM CT'S IN CHILDREN, WE FEEL THIS IS PROBABLY THE CAUSE OF HER LEUKEMIA. THERE ARE MULTIPLE RESEARCH ARTICLES BACKING THIS UP. THE CONE BEAM CT'S ARE NOTED TO POSE A 1 OUT OF TEN THOUSAND CHANCE OF DEVELOPING LEUKEMIA, ESPECIALLY IN GIRLS BECAUSE THEY ARE SMALLER. I HOPE YOU CAN HELP US. FDA SAFETY REPORT ID # (B)(4)." } ], "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": "" } ] }