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

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

Patient Problems Pain (1994); 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 day aligners, patient reported that they had to stop aligner wear due to root weakness and loose teeth on the bottom.Patient also reported pain, jaw discomfort, periodontitis, bleeding and sensitivity.Patient stated that they seen their dentist but no further information from the dental exam.Requested further information.

Manufacturer Narrative

Additional information received.We have received additional information for this event.A lor was received from the dentist that the patient had seen.The dentist reported that the patient was examined and was found to have weakened roots after reviewing a frontal panoramic radiology scan.This harm is irreparable, the byte aligners moved the patient's teeth so fast that it caused some of them to slightly detach from the bone.The patient stands to loose 1 to 3 of their bottom teeth as well as an unaligned bite and inflamed gums (periodontitis).The patient will need extraction of third molars (wisdom teeth) and is recommended to do this no later than 3 weeks due to the sensitivity and care needed for the state of the frontal roots.Doctor advised that the patient immediately stop using the aligners and check in two weeks afte the extraction of the molars to do tests that will determine if a dental implant is necessary for the two front bottom teeth (central incisors).

• 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: 19109407
• MDR Text Key: 340187416
• Report Number: 3014845255-2024-00239
• 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,Followup
• 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: 03/20/2024
• Initial Date FDA Received: 04/15/2024
• Supplement Dates Manufacturer Received: 03/20/2024
• Supplement Dates 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