BYTE CLEAR ALIGNERS
Received Apr 6, 2026 · Event occurred Aug 29, 2021
Report MW5186392 · MDR key 24794052
Device
Generic name
Aligner, Sequential
Manufacturer
Byte / Dentsply Sirona, Inc.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.