MAUDE Adverse Event Report: BYTE BYTE AT NIGHT ALIGNER KIT; ALIGNER, SEQUENTIAL

Model Number	231DD-C FOR ALIGNERS
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330); Numbness (2415)
Date of Event	05/10/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
I saw video ad for byte teeth aligner and reviews about the aligners and decided to order.I am in early 50's and i have crowded teeth esp on the bottom canines.It is not so severe so i opted for this option.I first had to do the cast which they send the equipment for impression sometime in december 2020, everything was packaged well and i was impressed that this is a legit company.After seeing so many positive reviews (probably paid or fake) i thought it was safe so went ahead and ordered the day and night aligners for $(b)(6) on (b)(6) 2021.I received them couple weeks later sometime in (b)(6).I started using them beginning of (b)(6) 2021.They were so tight that i would hardly get them on my teeth.They had provided a vibrating device to "shake " out the teeth so that the aligners can slide over the teeth.Even then i had difficulty.Since it was my first time wearing aligners i thought that maybe this was normal.In the morning when i removed the aligners, my teeth used to hurt and feel numb for an hour and i could only do my breakfast later in the morning.In this treatment we are supposed to go the next aligner after a week.I wasn't even getting comfortable with 1st one and immediately next week i have to use 2nd one which seemed impossible.It was truly torture for me and this company kept assuring me that their product works and kept asking me to send them pictures (which won't go easily through the emails).The "byteme" vibrating device didn't help much.It was so tight and hurting that i was forced to continue with the same aligners for another week before it got bearable.The morning pain and numbness was regular.My teeth felt weak and shaky.Every night i used to bite either my tongue or the skin inside my mouth with the aligners on.I continued thinking that aligners are associated with some discomfort.However, it was turning into a torture and i was seeing no result.But i continued like this for 3-4 months.I would send customer service an email and they would reply reassuring me that this treatment works and they have great reviews.I started asking some dentists and they said that the effect of such aligners is temporary and it is dangerous as there is no professional to monitor this.One orthodontist told me that she has a patient who tried this and other bones where teeth go in is pushed down and she will be loosing 6 teeth.This is harmful treatment promoted based on promoting fake ads and reviews.I went through lot of pain and was not seeing any result as i had already surpassed the specified duration without which the treatment works, so i stopped using i asked them for refund which they have denied.The problem is lot of customers must be getting ripped off as i am seeing some reviews on the internet.I don't see any (b)(6) reviews as this company knows how to manage online reputation.They sent me to materials to cast my impressions of teeth.After sending them they said i was a candidate for aligners.After ordering aligners (which they make.The aligners progressively go from your current teeth condition to straight which they claim to do it within 4 months! using the aligners along with a device called hyperbyte which vibrates your teeth so that they can wiggle to accommodate the aligners.Fda safety report id # (b)(4).

• Brand Name: BYTE AT NIGHT ALIGNER KIT
• Common Device Name: ALIGNER, SEQUENTIAL
• Manufacturer (Section D): BYTE; 1556 20th street; santa monica CA 90404
• MDR Report Key: 14282665
• Report Number: MW5109502
• Device Sequence Number: 5420414
• Product Code: OYH
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 04/30/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 231DD-C FOR ALIGNERS
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/03/2022
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SUPPLEMENTS LIKE VITAMINS AVAILABLE AT (B)(6).
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Weight: 77 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian, White