BYTE ALIGNERS

Description of Event or Problem

I EXPERIENCED ONGOING AND CUMULATIVE INJURIES AS A RESULT OF WEARING BYTE CLEAR ALIGNERS THAT WERE LATER ACKNOWLEDGED BY THE COMPANY AS DEFECTIVE. THE HARM DID NOT STOP AT THE INITIAL ONSET OF SYMPTOMS BUT CONTINUED TO PROGRESS THROUGHOUT TREATMENT AND AFTER TREATMENT WAS ABANDONED. I DEVELOPED PERSISTENT MALOCCLUSION, BITE CHANGES, PAIN, TOOTH MOBILITY, AND DENTAL DETERIORATION THAT REQUIRED PROFESSIONAL EVALUATION TO PREVENT FURTHER WORSENING. THE DEVICE FAILED TO FUNCTION AS INTENDED, AND REPLACEMENT TRAYS PROVIDED BY BYTE DID NOT FIT PROPERLY. I REPORTED THESE ISSUES TO THE COMPANY, BUT I WAS DENIED TIMELY REPLACEMENTS AND WAS NOT PROVIDED WITH A SUPERVISING DENTIST OR ADEQUATE CLINICAL OVERSIGHT. BYTE LATER ISSUED A "DEFECTIVE PRODUCT" NOTICE AND INFORMED ME THEY WERE "CONCLUDING BUSINESS" WITH ME, LEAVING ME WITHOUT APPROPRIATE FOLLOW-UP CARE DESPITE ONGOING SYMPTOMS. THE INJURIES I EXPERIENCED ARE CONTINUOUS IN NATURE. SYMPTOMS HAVE PERSISTED BEYOND THE TREATMENT PERIOD AND HAVE REQUIRED DENTAL INTERVENTION TO ASSESS AND MANAGE POTENTIAL LONG-TERM EFFECTS, INCLUDING BITE DYSFUNCTION AND RISK OF BONE OR PERIODONTAL DAMAGE. THESE ONGOING ISSUES ARE DIRECTLY ASSOCIATED WITH THE DEFECTIVE ALIGNERS AND THE LACK OF PROPER CLINICAL SUPERVISION DURING TREATMENT. I AM SUBMITTING THIS REPORT SO THE FDA IS AWARE OF THE DEVICE MALFUNCTION, THE PROGRESSION OF INJURY, AND THE POTENTIAL RISK TO OTHER CONSUMERS WHO MAY EXPERIENCE SIMILAR ONGOING HARM. NO CLINICAL TESTS, IMAGING, OR DIAGNOSTIC EVALUATIONS WERE PERFORMED BY BYTE. THE ONLY PRODUCT-RELATED PROCEDURE CONDUCTED WAS THE AT-HOME IMPRESSION KIT USED TO CREATE MOLDS FOR THE ALIGNERS. NO X-RAYS, DENTAL RECORDS, OR IN-PERSON EXAMINATIONS WERE OBTAINED OR REVIEWED BY THE COMPANY PRIOR TO APPROVING TREATMENT.