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

Device Problems Inadequacy of Device Shape and/or Size (1583); Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Deformity/ Disfigurement (2360); Tissue Breakdown (2681)

Event Type  Injury  

Event Description

While using a byte night aligner, patient reported that roots are exposed; bottom row of teeth have shifted and fallen forward and is getting worse.They can barely open their jaw in the morning and feels locked and hurts most of the day; and there is something going wrong with their bite.Patient was advised to discontinue treatment; they were seen by an orthodontist to determine the amount of damage done and see what treatment is now needed.

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: dan eagar ; 221 w. philadelphia st.; york, PA 17401 ; 7178494593
• MDR Report Key: 18926604
• MDR Text Key: 337944586
• Report Number: 3014845255-2024-00179
• 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: 03/18/2024

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: Lay User/Patient
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/29/2024
• Initial Date FDA Received: 03/18/2024
• 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