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); Tissue Breakdown (2681)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Since this event resulted in a serious injury, it is reportable per 21 cfr part 803.
Event or Problem Description
Patient stated that they experienced tmj and gum damage due to byte retainer.

• 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 ; 7178457511
• MDR Report Key: 25653307
• Report Number: 3031789024-2026-02813
• Device Sequence Number: 9750077
• Product Code: KMY
• UDI-Device Identifier: 00850017524187
• UDI-Public: 00850017524187
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 06/29/2026

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: MN1801BBRT
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 06/12/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2026
• Initial Report FDA Received Date: 06/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/04/2025
• 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