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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device tongue suspension system
Regulation Description Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea.
Definition Intended to be used for anterior advancement of the tongue base by means of a bone screw threaded with a suture. It is indicated for the treatment of obstructive sleep apnea (OSA) and/or snoring.
Product CodeORY
Regulation Number 872.5570
Device Class 2


Premarket Reviews
ManufacturerDecision
SIESTA MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2020 2 2
2022 2 2
2023 20 20
2024 11 11
2025 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 21 21
Break 3 3
Insufficient Information 2 2
Lack of Effect 2 2
Detachment of Device or Device Component 2 2
Material Fragmentation 2 2
Device Dislodged or Dislocated 1 1
Migration or Expulsion of Device 1 1
Inadequacy of Device Shape and/or Size 1 1
Improper or Incorrect Procedure or Method 1 1
Material Split, Cut or Torn 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 5 5
Implant Pain 5 5
No Clinical Signs, Symptoms or Conditions 5 5
Discomfort 4 4
Apnea 3 3
Post Operative Wound Infection 3 3
Skin Infection 3 3
Speech Disorder 2 2
Neck Pain 2 2
Choking 2 2
Anemia 1 1
Dysphagia/ Odynophagia 1 1
Emotional Changes 1 1
Headache 1 1
Hearing Impairment 1 1
Hemorrhage/Bleeding 1 1
Failure of Implant 1 1
Patient Problem/Medical Problem 1 1
Paresthesia 1 1
Deformity/ Disfigurement 1 1
Pharyngitis 1 1
Inadequate Pain Relief 1 1
Sore Throat 1 1
Pain 1 1
Paresis 1 1
Seroma 1 1
Difficulty Chewing 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

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