CONE BEAM CT
Received Dec 14, 2021 · Event occurred Aug 19, 2021
Report MW5106062 · MDR key 13011772
Device
Generic name
System, X-ray, Extraoral Source, Digital
Manufacturer
TrophyProduct problems
- Labelling, Instructions for Use or Training Problem
- Patient-Device Incompatibility
Patient
33 YR · Female
- Cancer
- Cancer
Narrative
Description of Event or Problem
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).