MAUDE Adverse Event Report: SIESTA MEDICAL, INC. ENCORE SYSTEM; INTRAORAL DEVICE FOR SNORING AND SLEEP APNEA

Model Number	FG0002
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Skin Infection (4544)
Date of Event	04/10/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The physician treated the patient with a hyoid suspension using the encore system.The patient later developed an infection in the upper incision site of the bone anchor placement.The patient was given a course of antibiotics and a layered closure was made to isolate the infection.

• Brand Name: ENCORE SYSTEM
• Common Device Name: INTRAORAL DEVICE FOR SNORING AND SLEEP APNEA
• Manufacturer (Section D): SIESTA MEDICAL, INC.; 101 church st.; suite 3; los gatos CA 90030
• Manufacturer (Section G): SIESTA MEDICAL, INC.; 101 church st.; suite 3; los gatos CA 90030
• Manufacturer Contact: michael kolber ; 101 church st.; suite 3; los gatos, CA 90030 ; 4083209424
• MDR Report Key: 25124767
• Report Number: 3008792120-2026-00001
• Device Sequence Number: 21506500
• Product Code: ORY
• UDI-Device Identifier: 00862211000206
• UDI-Public: (01)00862211000206(17)250930(10)1244
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K213159
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/08/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: FG0002
• Device Lot Number: 1244
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2026
• Initial Report FDA Received Date: 05/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/02/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown