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

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

Patient Problems Deformity/ Disfigurement (2360); Sensitivity of Teeth (2427); Increased Sensitivity (4538)

Event Type  Injury  

Event Description

While using a byte day aligners, patient reports that their bottom teeth are beginning to crowd, they did not have this before starting treatment.They also reported that their teeth are sensitive to hot and cold; when they remove the aligners their teeth are super sensitive and feel like they could fall out.Patient's two front teeth feel loose.They also reported discolored teeth despite using products to remove stains.Patient was asked for video showing mobility, they were instructed on how to reduce staining and that a possible rest period might be needed depending on their responses back.

Manufacturer Narrative

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

• Brand Name: BYTE DAY 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: 19125970
• MDR Text Key: 340393158
• Report Number: 3014845255-2024-00254
• 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: 04/17/2024

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: 03/24/2024
• Initial Date FDA Received: 04/17/2024
• 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