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

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

Patient Problems Pain (1994); Deformity/ Disfigurement (2360)

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 retainer, patient reported that they have had major teeth pain, they had to have re-treats to root canals, went to a specialist who ground down their teeth because their teeth moved out of alignment that any time, they chewed they only chewed on 1 or 2 teeth.The patient was examined by their orthodontic specialist due to significant distress with their bite and tmj.The specialist, in their professional opinion, the patient was not a candidate for byte aligner treatment because of the limitations in aligning only the anterior dentition without managing the posterior occlusion, the result was a creation of a reverse (brody) crossbite tendency with significant balancing contact interferences upon both lateral and protrusive excursive movements.In the patient's case, this resulted in a traumatic occlusion which resulted in significant pain on her right side leading to a need for a root canal and crown.Patient's tmj has suffered tremendously from the imbalance in the patient's bite affecting her quality of life.After managing pain on the right side, the left side developed acute inflammation due to limitations to chew only on that side.Orthodontic specialist recommended comprehensive ortho treatment to restore proper posterior occlusion and remove the balancing contact interferences.

• Brand Name: BYTE RETAINER
• 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: 19008669
• MDR Text Key: 338978766
• Report Number: 3014845255-2024-00209
• Device Sequence Number: 1
• Product Code: NXC
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2024
• 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: 03/14/2024
• 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