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

Model Number	BYTERETAINERTRAY
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Defective Device (2588); Sharp Edges (4013)
Health Effect - Clinical Codes	Abscess (1690); Hypersensitivity/Allergic reaction (1907); Laceration(s) (1946); Necrosis (1971); Deformity/ Disfigurement (2360); Tooth Fracture (2428); Swelling/ Edema (4577); Tooth Loss (4831)
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
It was alleged that byte¿s products have caused a broad range of complications, including but not limited to, allergic reactions, bite misalignment, bone loss, breaking and chipping of teeth, cutting of gums due to aligners¿ sharp edges, facial swelling and abscess in mouth, gum recession, necrosis, tooth fractures, and worsening of patient bite.

• 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: 24815583
• Report Number: 3031789024-2026-02711
• Device Sequence Number: 18563682
• Product Code: KMY
• UDI-Device Identifier: 00850017524187
• UDI-Public: 00850017524187
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 04/08/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: BYTERETAINERTRAY
• Device Catalogue Number: PRS-0063
• Device Lot Number: MD8191BRRT
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/03/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2026
• Initial Report FDA Received Date: 04/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/08/2024
• 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: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 38 YR
• Patient Sex: Female