BYTE ALIGNERS
Received Sep 3, 2025 · Event occurred Jun 20, 2025
Report MW5175588 · MDR key 22955608
Device
Generic name
Aligner, Sequential
Manufacturer
Straight Smile, Llc/dentsply Sirona, Inc.Product problems
- Therapeutic or Diagnostic Output Failure
Patient
39 YR · Female
- Tooth Fracture
- Unspecified Tissue Injury
- Tooth Fracture
- Unspecified Tissue Injury
Narrative
Description of Event or Problem
I PURCHASED BYTE ALIGNERS FOR $2,399. A MOLAR THAT WAS ALREADY NOTED AS FRACTURED IN MY INITIAL IMPRESSIONS WORSENED AND EVENTUALLY BROKE APART WHILE WEARING THE ALIGNERS. DESPITE SUBMITTING WEEKLY PROGRESS PHOTOS, NO MEANINGFUL OVERSIGHT OCCURRED UNTIL I REQUESTED MY FINAL ALIGNERS. AT THAT POINT, I WAS TOLD TO BACKTRACK IN TREATMENT AND ULTIMATELY INSTRUCTED TO STOP USING THE ALIGNERS ALTOGETHER. THIS ALIGNS WITH RISKS BYTE ITSELF ACKNOWLEDGED IN ITS FDA FIELD SAFETY NOTIFICATION, INCLUDING INADEQUATE PATIENT SCREENING AND TOOTH FRACTURE AS POTENTIAL OUTCOMES. BYTE ACCEPTED ME INTO TREATMENT DESPITE VISIBLE FRACTURE AT THE START, WHICH DIRECTLY LED TO INJURY. OUTCOME: DIRECT HARM (TOOTH FRACTURE/LOSS), UNUSABLE PRODUCT, $2,399 FINANCIAL LOSS, ADDITIONAL OUT-OF-POCKET DENTAL CARE REQUIRED.