CONE BEAM 3D IMAGE

Description of Event or Problem

REPORT OF ADVERSE MEDICAL EVENT DATE: (B)(6) 2019. SOURCE: (B)(6) DENTISTRY. (B)(6). EVENT DESCRIPTION: AN APPOINTMENT WAS SCHEDULED FOR (B)(6) CONCERNING A BROKEN CAP AND TOOTH IN THE TOP CENTER OF HIS MOUTH. (B)(6), HIS WIFE, WAS INFORMED THAT THE DENTAL OFFICE WAS HOLISTIC AND USED OZONE TREATMENTS AND LASER SURGERY. SHE WAS INFORMED THAT A CONE BEAM 3D IMAGE WOULD BE REQUIRED EVEN THOUGH (B)(6) HAD BROUGHT TWO OTHER DENTAL X-RAYS WITH HIM THAT WERE TAKEN A FEW DAYS BEFORE. THE CONE BEAM 3D IMAGE WAS ORDERED BY DR. (B)(6). FOLLOWING THE IMAGING, WITHIN AN HOUR LATER, (B)(6) EXPERIENCED A SUDDEN SHARP PAIN AND CRAMPING IN HIS NECK SUCCEEDED BY A HEADACHE ON THE TOP OF HIS HEAD LASTING FOR A FEW HOURS. THIS ADVERSE EVENT REPORT MUST BE FORWARDED TO THE APPROPRIATE AUTHORITIES. (B)(6). FDA SAFETY REPORT ID # (B)(4).