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

Model Number	FG-0002
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Implant Pain (4561)
Date of Event	10/11/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was implanted with an encore system and approximately 2 1/2 months later developed a self-limiting stitch abscess.The patient received 2 doses of steroids and antibiotics.The device was later explanted, the wound healed and the patient is doing well.

• 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: 16242214
• Report Number: 3008792120-2023-00006
• Device Sequence Number: 6606097
• Product Code: ORY
• UDI-Device Identifier: 00862211000206
• UDI-Public: 00862211000206
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K213159
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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): 01/25/2023

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: FG-0002
• Device Lot Number: 0907
• 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: 10/11/2022
• Initial Report FDA Received Date: 01/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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