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 Code	Tooth Fracture (2428)
Type of Reportable Event	Serious Injury
Event or Problem Description
Customer stated they chipped their front tooth due to the retainers.Contraindicated.
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 ; 7178457511
• MDR Report Key: 24722349
• Report Number: 3031789024-2026-02676
• Device Sequence Number: 10133261
• 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): 03/27/2026

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: MD4101KRRT
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 03/25/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/25/2026
• Initial Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2024
• 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: Female