MAUDE Adverse Event Report: STRAIGHT SMILE LLC BYTE RETAINER; POSITIONER, TOOTH, PREFORMED

Model Number	BYTERETAINERTRAY
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Unspecified Musculoskeletal problem (4535)
Type of Reportable Event	Serious Injury
Event or Problem Description
Customer stated their underbite worsened due to the retainers.
Additional Manufacturer Narrative
Since this event resulted in a serious injury, it is reportable per 21 cfr part 803.
Additional Manufacturer Narrative
A dhr review was conducted with no discrepancies noted.

• 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: 25029873
• Report Number: 3031789024-2026-02742
• Device Sequence Number: 10126997
• Product Code: KMY
• UDI-Device Identifier: 00850017524187
• UDI-Public: 00850017524187
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2026

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: MD3341ODRT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 04/05/2026
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/05/2026
• Supplement Date Received by Manufacturer: 07/06/2026
• Initial Report FDA Received Date: 04/29/2026
• Supplement Report FDA Received Date: 07/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/14/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown