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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOMNOMED SOMNOMED; DEVICE, ANTI-SNORING
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SOMNOMED SOMNOMED; DEVICE, ANTI-SNORING Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Apnea (1720); Sensitivity of Teeth (2427)
Event Type  Injury  
Event Description
In 2013, i was fitted by a dentist with a somnomed dental appliance for sleep apnea.Within a year of constant nighttime wearing as prescribed, my bite became extremely compromised; only one top front tooth and only one bottom tooth touched.I discontinued wearing it and sought bite correction via traditional braces from an orthodontist.Braces were worn for 2 years which resulted in a perfect bite.However, the apnea issues worsened and i tried yet another appliance with another dentist.In 2017, i was fitted with a tap3 dental appliance for sleep apnea.Again, within a year of constant nighttime wearing as prescribed, my bite became compromised with top front teeth touching bottom front teeth.To alleviate this bite issue, the prescribing dentist fitted bottom front teeth with veneers, which altered the bite further to a slight underbite.Both products should have definitely stated in plain language that bite alterations/changes can and most likely will occur, rather than giving users false hope via prescribed exercises which i followed.Fda safety report id# (b)(4).
 
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Brand Name
SOMNOMED
Type of Device
DEVICE, ANTI-SNORING
Manufacturer (Section D)
SOMNOMED
MDR Report Key10785313
MDR Text Key214798252
Report NumberMW5097630
Device Sequence Number1
Product Code LRK
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 10/31/2020
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received11/03/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Was Device Available for Evaluation? Yes
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Weight68
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