MAUDE Adverse Event Report: BYTE INVISIBLE BRACES BYTE ALIGNERS; ALIGNER, SEQUENTIAL

Device Problem Unexpected Therapeutic Results (1631)

Patient Problems Sensitivity of Teeth (2427); No Code Available (3191)

Event Date 06/29/2020

Event Type  Injury  

Event Description

Pt reported she used the byte aligner for 8 weeks.On (b)(6) 2020, after wearing the aligners overnight, she woke up with her front top tooth discolored.She described it as a dark gray blue color.She went to her dentist for an emergency appointment.She stated that her dentist informed her that the tooth shifted too quickly and caused blood to go into her tooth.He instructed her to stop using the aligner immediately.She was told to take 12 advil a day for 6 to 8 weeks and see if the blood will drain on its own.If not she will have to have root canal therapy to save her tooth.She is very upset and has attempted to contact the (b)(6) dental association as instructed by her dentist.She hopes that byte will stop payments.

• Brand Name: BYTE ALIGNERS
• Type of Device: ALIGNER, SEQUENTIAL
• Manufacturer (Section D): BYTE INVISIBLE BRACES; 12100 wilshire blvd, ; los angeles CA 90025
• MDR Report Key: 10233221
• MDR Text Key: 197820920
• Report Number: MW5095374
• Device Sequence Number: 1
• Product Code: NXC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/02/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 23 YR
• Patient Weight: 60