MAUDE Adverse Event Report: STRAIGHT SMILE LLC Byte Retainer; Positioner, Tooth, Preformed

Model Number	BYTERetainerTray
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Deformity/ Disfigurement (2360); Tooth Fracture (2428)
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient stated that they experienced a broken tooth and bite concerns due to byte retainer.
Additional Manufacturer Narrative
Since this event resulted in a serious injury, it is reportable per 21 cfr part 803.

• Brand Name: Byte Retainer
• Common Device Name: Positioner, Tooth, Preformed
• Manufacturer (Section D): STRAIGHT SMILE LLC; 3301 n thanksgiving way; lehi UT 84043
• Manufacturer (Section G): STRAIGHT SMILE LLC; 3301 n thanksgiving way; lehi UT 84043
• Manufacturer Contact: dan eagar ; 221 west philadelphia st.; york, PA 17401 ; +1(717)845-7511
• MDR Report Key: 50017628
• Report Number: 3031789024-2026-02837
• Device Sequence Number: 13145385
• Product Code: KMY
• UDI-Device Identifier: 00850017524187
• UDI-Public: 00850017524187
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/24/2026

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
• Operator of Device: Lay User/Patient
• Device Model Number: BYTERetainerTray
• Device Catalogue Number: PRS-0063
• Device Lot Number: MD6731SMRT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2026
• Initial Report FDA Received Date: 07/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/14/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female