MAUDE Adverse Event Report: STRAIGHT SMILE , LLC BYTE NIGHT ALIGNER; ALIGNER, SEQUENTIAL

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Deformity/ Disfigurement (2360)

Event Type  Injury  

Event Description

While using a byte night aligner, the patient, who has been wearing byte aligners for the past 2.5 years, the use of the aligners has created a significant anterior open bite.Patient's teeth do not fit together properly in the posterior or the anterior.Majority of occlusal contact is on the 3rd molars on the right side.There appears to have been super-eruption of the posterior molars; especially the 3rd molars; most likely due to not being covered by the aligner trays.Patient will require a comprehensive orthodontic treatment with either traditional braces or aligners that can utilize attachments, such as invisalign.Doctor also recommends removal of the 3rd molars.Anticipated treatment time is approximately 12 months.Doctor advised patient to discontinue use of the byte aligners as they have caused a malocclusion (anterior open bite) and are continuing to make it worse.

Manufacturer Narrative

Since this event resulted in a serious injury, it is reportable per 21 cfr part 803.

• Brand Name: BYTE NIGHT ALIGNER
• Type of Device: ALIGNER, SEQUENTIAL
• Manufacturer (Section D): STRAIGHT SMILE , LLC; 1556 20th st. , suite a; santa monica CA 90404
• Manufacturer (Section G): STRAIGHT SMILE , LLC; 1556 20th st. , suite a; santa monica CA 90404
• Manufacturer Contact: hannah seevaratnam ; 221 w. philadelphia st.; york, PA 17401 ; 7178494593
• MDR Report Key: 17898129
• MDR Text Key: 325240853
• Report Number: 3014845255-2023-00092
• Device Sequence Number: 1
• Product Code: NXC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180346
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/05/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention