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

Model Number	FG0002
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Skin Infection (4544)
Date of Event	06/20/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The physician reported the patient was treated with the encore system on 11/16/2023.The initial treatment went well, however the incision was later noted to be "oozing".A negative culture was reported.
Event or Problem Description
The physician reported the patient was treated with the encore system on (b)(6) 2023.The initial treatment went well, however the incision was later noted to be "oozing".A negative culture was reported.The patient later returned to the clinic and on (b)(6) 2024 and the device was explanted without issue.The tissue culture was positive and identified as kliebsiella aerogens.

• Brand Name: ENCORE SYSTEM
• Common Device Name: INTRAORAL DEVICE FOR SNORING AND OBSTRUCTIVE 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 ; 4083209424
• MDR Report Key: 18678453
• Report Number: 3008792120-2024-00003
• Device Sequence Number: 6167186
• Product Code: ORY
• UDI-Device Identifier: 00862211000206
• UDI-Public: (01)00862211000206(17)250930(10)1058
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K213159
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2024

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: 09/30/2025
• Device Model Number: FG0002
• Device Lot Number: 1058
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2024
• Supplement Date Received by Manufacturer: 06/20/2024
• Initial Report FDA Received Date: 02/09/2024
• Supplement Report FDA Received Date: 07/20/2024
• 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: Male