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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIESTA MEDICAL, INC. ENCORE SYSTEM; INTRAORAL DEVICE FOR SNORING AND OBSTRUCTIVE SLEEP APNEA
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SIESTA MEDICAL, INC. ENCORE SYSTEM; INTRAORAL DEVICE FOR SNORING AND OBSTRUCTIVE SLEEP APNEA Back to Search Results
Model Number FG0002
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Discomfort (2330)
Event Date 07/26/2016
Event Type  Injury  
Event Description
The physician performed a hyoid and tongue suspension using the encore system.Eight months later the patient reported with irritation and a granuloma in the submental area around the implanted bone anchors.
 
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Brand Name
ENCORE SYSTEM
Type of Device
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 Key17102422
MDR Text Key316931470
Report Number3008792120-2023-00015
Device Sequence Number1
Product Code ORY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K133680
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial
Report Date 06/09/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/11/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date01/01/2015
Device Model NumberFG0002
Device Lot Number0292
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/27/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/01/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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