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

Model Number	FG0002
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Apnea (1720)
Date of Event	03/26/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient reported that the initial procedure was not effective.A follow-up examination by a second physician noted that the sutures were insufficiently tensioned.A third physician performed a sleep study and airway examination.A second procedure, consisting of either a tongue suspension or tightening of the existing sutures, did not resolve the patients snoring.

• Brand Name: ENCORE SYSTEM
• Common Device Name: INTRAOORAL DEVICE FOR SNORING AND SLEEP APNEA
• Manufacturer (Section D): SIESTA MEDICAL, INC.; 101 church street; suite 3; los gatos CA 95030
• Manufacturer (Section G): SIESTA MEDICAL, INC.; 101 church street; suite 3; los gatos CA 95030
• Manufacturer Contact: michael kolber ; 101 church street; suite 3; los gatos, CA 95030
• MDR Report Key: 19164296
• Report Number: 3008792120-2024-00005
• Device Sequence Number: 7435697
• Product Code: ORY
• UDI-Device Identifier: 00862211000206
• UDI-Public: (01)00862211000206(17)220131(10)0678
• Combination Product (Y/N): N
• PMA/510(K) Number: K213159
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/23/2024

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 Expiration Date: 01/31/2022
• Device Model Number: FG0002
• Device Lot Number: 0678
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2024
• Initial Report FDA Received Date: 04/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Unknown