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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Sensitivity of Teeth (2427); Increased Sensitivity (4538)

Event Type  Injury  

Event Description

While using byte night aligners, tooth #25 was discolored and sensitive to hot and cold.Pt.Saw dentist and will require root canal therapy on two of her teeth.

Manufacturer Narrative

Since this event required medical intervention to preclude permanent impairment/damage to a body function/structure, 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 20tth st. , suite a; santa monica CA 90404
• Manufacturer (Section G): STRAIGHT SMILE, LLC; 1556 20tth st. , suite a; santa monica CA 90404
• Manufacturer Contact: hannah seevaratnam ; 221 w. philadelphia st.; suite 60w; york, PA 17401 ; 7178494593
• MDR Report Key: 15609728
• MDR Text Key: 301814438
• Report Number: 3014845255-2022-00023
• 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: 10/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2022
• 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: 06/30/2022
• Was Device Evaluated by Manufacturer?: 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