Description of Event or Problem · 1
THIS SPONTANEOUS REPORT WAS RECEIVED FROM A CONSUMER ON (B)(6) 2012, AND AT THIS TIME WAS CLASSIFIED AS NON-SERIOUS. THE CONSUMER REPORTS THAT SHE STARTED TO WEAR THE NIGHTGUARD ONE YEAR PRIOR TO HER CALL, STARTING IN APPROXIMATELY (B)(6) 2011. SHE WORE IT EVERY NIGHT. SHE HAS WORN THE SAME NIGHTGUARD THE ENTIRE YEAR. STARTING IN APPROXIMATELY (B)(6) 2012, SHE NOTICED HER BITE SEEMED "OFF." SHE FEELS LIKE HER TOP TEETH SHIFTED. SHE WENT TO HER DENTIST ON (B)(6) 2012 FOR A CLEANING AND TO CHECK HER TEETH AND HER DENTIST ADVISED HER TO DISCONTINUE WEARING THE NIGHTGUARD. NO FURTHER INFORMATION WAS PROVIDED. FOLLOW-UP INFORMATION RECEIVED FROM THE CONSUMER AND HER DENTIST ON (B)(6) 2013 UPGRADING THE CASE TO SERIOUS. THE CONSUMER REPORTS THAT DUE TO HER TEETH SHIFTING, SHE IS NOT CHEWING FOOD PROPERLY AND HAS IMPAIRED SPEECH AS SHE HAS DEVELOPED A LISP. HER DENTIST REPORTS THAT HE EVALUATED HER ON (B)(6) 2012 WITH A CHIEF COMPLAINT OF "TEETH NOT CLOSING." HIS EXAM SHOWED TEETH #2, #15, #10, #31 WERE IN OCCLUSION. ALL OTHER TEETH WERE OUT OF OCCLUSION. HE REPORTS THAT THERE WAS ALSO ABOUT A 5 MILLIMETER (MM) DISTANCE BETWEEN MAXILLARY ANTERIOR AND MANDIBULARY ANTERIOR TEETH. HE LOWERED ERUPTED #2 AND #15 APPROXIMATELY 2 MM, BUT THERE IS STILL APPROXIMATELY A 3 MM OPENING BETWEEN ANTERIORS. HE RECOMMENDED ORTHODONTIC TREATMENT TO CORRECT THE PROBLEM.