inforMED
InjuryNXC

BYTE CLEAR ALIGNERS

Received Apr 6, 2026 · Event occurred Aug 29, 2021

Report MW5186392 · MDR key 24794052

Device

Generic name

Aligner, Sequential

Patient

33 YR · Female

  • Pain
  • Discomfort
  • Skin Inflammation/ Irritation
  • Unspecified Tissue Injury
  • Swelling/ Edema

Narrative

Description of Event or Problem

I USED BYTE CLEAR ALIGNERS AS DIRECTED UNDER THEIR TREATMENT PLAN. WHEN I REACHED ALIGNER #3, I EXPERIENCED SIGNIFICANT GUM INJURY, PAIN, AND DISCOMFORT. THE ALIGNER APPEARED TO FIT IMPROPERLY AND CAUSED IRRITATION TO MY GUMS. I WAS UNABLE TO CONTINUE TREATMENT DUE TO THE PAIN AND INJURY. BYTE REQUIRED ME TO REDO IMPRESSIONS MULTIPLE TIMES DUE TO IMPROPER FIT AND ONGOING ISSUES. DESPITE THESE ATTEMPTS, THE ALIGNERS CONTINUED TO CAUSE DISCOMFORT AND WERE NOT SUITABLE FOR SAFE TREATMENT PROGRESSION. I STOPPED USING THE ALIGNERS DUE TO GUM INJURY AND PAIN. I CONTACTED BYTE AND REQUESTED A REFUND DUE TO TREATMENT FAILURE AND PHYSICAL HARM. BYTE DENIED MY REFUND AND HAS NOT RESPONDED TO FOLLOW-UP COMMUNICATIONS. THIS INCIDENT RESULTED IN GUM INJURY, PAIN, AND INABILITY TO SAFELY CONTINUE TREATMENT. I AM ATTACHING PHOTOS SHOWING SWOLLEN AND RAISED GUM TISSUE ABOVE MY UPPER FRONT TEETH WHILE USING BYTE ALIGNER #3. THE AREA BECAME PAINFUL AND IRRITATED WHILE WEARING THE ALIGNER, AND I WAS UNABLE TO CONTINUE TREATMENT SAFELY.