FDA Adverse Event Injury Summary report: N

BYTE CORRECTIVE ALIGNERS

MDR report key: 21549397 · Received March 7, 2025

Report

Report Number
MW5167395
Event Type
Injury
Date Received
March 7, 2025
Date of Event
January 10, 2024
Report Date
March 3, 2025
Manufacturer
STRAIGHT SMILE, LLC.
Product Code
NXC
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
CA, US
Reporter Occupation
PATIENT
Health Professional
*

Narratives

Description of Event or Problem · 0

FIRST, I'D LIKE TO SAY THAT I HAD HIGH HOPES FOR THIS COMPANY AND PRODUCT. AS A NAIVE YOUNG MILLENNIAL, WE'RE ALL LOOKING FOR THOSE NEW, INNOVATIVE "FAST FIXES." HOWEVER, BUYER BE WARNED. I COMPLETED TREATMENT AS OUTLINED BUT HAD TROUBLE UPLOADING MY PROGRESS REPORTS AND TAKING ALL THE PHOTOS DUE TO MY CRAZY SCHEDULE. I DID HOWEVER COMPLETE THE FULL TERM OF TREATMENT, MOVING TO NEXT ALIGNERS AT THE PRESCRIBED WEEKS, USING THE HYPERBYTE DAILY. MY FIRST MONTH WAS HORRENDOUSLY PAINFUL. I WAS NAUSEOUS AND HAD CONSTANT HEADACHES, AND JAW PAIN WHICH WAS NOT DISCLOSED AS A POTENTIAL TREATMENT SYMPTOM. I HAD TO GOOGLE THIS EXTENSIVELY TO FIND OUT THAT NERVES MOVING TOO QUICKLY IN THE MOUTH CAN CAUSE THESE SYMPTOMS. BYTE SUPPORT GIVES YOU THE RUNAROUND AND TAKES WEEKS TO GET BACK TO YOU REGARDING YOUR TREATMENT QUESTIONS AND THEN ASKS YOU FOR THE SAME ANSWERS AND SAME PHOTOS MULTIPLE TIMES. INITIAL TREATMENT EXPECTATIONS WERE MESSED UP FROM THE BEGINNING. IT SAID I WOULD HAVE 13 SETS ON THE INITIAL INTAKE. I RECEIVED 9 BUT MY APP SAID 11. HAD TO REACH OUT AGAIN AND SEND MULTIPLE ROUNDS OF THE SAME PHOTOS OVER AND OVER AGAIN TO GET TREATMENT CONTINUED AS BOTH MY TOP AND BOTTOM TEETH CLEARLY WERE NOT SET CORRECTLY YET. FINALLY GOT THE NEXT SET, DID THE NEXT ROUNDS, STILL HOPEFUL AT THIS POINT. STILL DID NOT FIX THE PROBLEM AND CREATED A GAP IN MY LOWER JAW AND OVERCORRECT THE LOWER SO MY TEETH DO NOT LINE UP NOW AND ONE OF MY UPPER TEETH IS PUSHED DOWN IN THIS WEIRD WAY. IN THIS TIME, WENT TO THE DENTIST FOR THE FIRST TIME IN A COUPLE YEARS. THEY TOOK X-RAYS AND REPORTED THAT MY LIGAMENTS WERE WIDENED. HAVEN'T HAD BRACES FOR OVER 15 YEARS SO NO OTHER REASON WHY THAT WOULD BE. DON'T KNOW EXACTLY WHAT THAT MEANS BUT THEY TOLD ME TO DISCONTINUE USE OF BYTE IMMEDIATELY. SO, I THINK WE CAN ASSUME IT'S PROBABLY BAD. REACHED OUT WANTING MY FINAL RETAINERS TO JUST BE DONE WITH THIS WHOLE MESS AND SPOKE TO A VERY NICE GAL WHO SAID THEY WANTED ME TO BE COMPLETELY SATISFIED WITH MY TREATMENT. STILL HOPEFUL. WELL, THAT'S NOT TRUE BECAUSE I GOT ANOTHER EMAIL TODAY SAYING MY BYTE GUARANTEE WAS NOT APPLICABLE AND THEY WANT ANOTHER $700 TO CONTINUE. I'M NOW OUT $1400, HAVE A MESSED-UP SMILE, AND WIDENED TOOTH LIGAMENTS. WORST PART IS, BECAUSE I DIDN'T GET X RAYS BEFORE TREATMENT, BYTE WON'T DO ANYTHING ABOUT IT. MY ADVICE WOULD BE TO GO TO YOUR DENTIST AND DON'T MESS WITH YOUR MOUTH. BYTE, YOU NEED MAKE IT MORE CLEAR TO YOUR CUSTOMERS THE POSSIBLE SIDE EFFECTS AND IMPLICATIONS OF TREATMENT OR AT LEAST BE WILLING TO FIX YOUR OWN MISTAKES WITHOUT CHARGING YOUR CUSTOMERS AGAIN IN CASES LIKE MINE WHERE YOU MESSED UP FROM THE BEGINNING. THIS IS PEOPLE'S MOUTH'S WE'RE TALKING ABOUT. YOU ONLY GET ONE SET OF TEETH. CONE BEAM SCAN DONE BY MY DENTIST SHOWED WIDENED TOOTH LIGAMENTS.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
338635 BYTE CORRECTIVE ALIGNERS ALIGNER, SEQUENTIAL NXC STRAIGHT SMILE, LLC.

Patients

Seq Age Sex Outcome Treatment
1 35 YR Female Other