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

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

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

Event Type  Injury  

Manufacturer Narrative

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

Event Description

While using a byte night aligners, patient was examined by their dentist, after comprehensive clinical and radiographic evaluation, it was found that the patient has lower anterior teeth that are loose and causing pain.#26 needs a root canal and has been scheduled.Dentist recommended stopping aligner treatment immediately and to focus on getting the patient's teeth stable and out of pain.

• 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: 18945273
• MDR Text Key: 338185699
• Report Number: 3014845255-2024-00195
• 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: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2024
• 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: 03/04/2024
• 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