SOMNODENT

Additional Manufacturer Narrative

(B)(4). FROM THE FDA FORWARDED, VOLUNTARY REPORT SOMNOMED DOES NOT CONCLUDE THAT THIS REPORT REPRESENTS A DEATH, SERIOUS INJURY OR REPORTABLE MALFUNCTION. THIS RESPONSE IS INTENDED TO RESPOND TO MW5063669. TMD IS NOT A PERMANENT IMPAIRMENT OR LIFE THREATENING. WARNINGS ARE DISCLOSE THAT USE OF THESE DEVICES MAY CAUSE: TOOTH MOVEMENT OR CHANGES IN DENTAL OCCLUSION AND PAIN OR SORENESS TO THE TEMPOROMANDIBULAR JOINT. THE REPORTED EVENT IS A KNOWN INHERENT RISK OF THE PROCEDURE. NOT RETURNED.

Description of Event or Problem

A PATIENT COMPLETED A VOLUNTARILY EVENT REPORT ON (B)(6) 2016, WHICH GENERATED MW5063669 REPORT. THE PATIENT WAS DIAGNOSED WITH SLEEP APNEA AROUND 2015 AND RECEIVED A SOMNOMED ORAL DENTAL DEVICE AROUND 2015. THE PATIENT DID NOT HAVE ANY PROBLEMS OR PAIN AT FIRST. THE DENTIST HAD TO ADJUST THE DEVICE OVER A PERIOD OF 3 VISITS TO REACH THE OPTIMAL POSITION. AFTER ONE MORNING IN 2016, THE PATIENT'S JAW WAS "ESSENTIALLY DISLOCATED" UNTIL LUNCH TIME. THE PATIENT EXPERIENCED PAIN TRYING TO GET THE JAW BACK INTO POSITION. THIS HAPPENED MULTIPLE TIMES UNTIL THE PATIENT RETURNED TO THE DENTIST TO ADJUST THE DEVICE BACKWARDS; HOWEVER, THE PATIENT WAS STILL EXPERIENCING JAW ALIGNMENT ISSUES AT THE TIME OF THE REPORT. THE DENTIST TOLD THE PATIENT THAT HE/SHE MIGHT HAVE HAD A PREDISPOSITION TO TEMPOROMANDIBULAR JOINT DISORDER. THE PATIENT SAID THAT THE DENTIST DID NOT COMMUNICATE THAT PRIOR TO OBTAINING THE MEDICAL DEVICE.