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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device splint, intranasal septal
Product CodeLYA
Regulation Number 874.4780
Device Class 1


Premarket Reviews
ManufacturerDecision
BIOMED ENT, INC.
  SUBSTANTIALLY EQUIVALENT 1
GYRUS ACMI, INC
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC XOMED
  SUBSTANTIALLY EQUIVALENT 1
SPIWAY, LLC
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2018 19 19
2019 5 5
2020 6 6
2021 19 19
2022 8 8
2023 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Material Integrity Problem 12 12
Adverse Event Without Identified Device or Use Problem 10 10
Packaging Problem 10 10
Use of Device Problem 3 3
Patient-Device Incompatibility 3 3
Migration or Expulsion of Device 3 3
Device Operates Differently Than Expected 3 3
Insufficient Information 3 3
Activation Failure 2 2
Unexpected Therapeutic Results 2 2
Material Too Rigid or Stiff 2 2
Inadequacy of Device Shape and/or Size 1 1
Nonstandard Device 1 1
Unsealed Device Packaging 1 1
Material Discolored 1 1
Material Disintegration 1 1
Difficult to Insert 1 1
Labelling, Instructions for Use or Training Problem 1 1
Contamination /Decontamination Problem 1 1
Microbial Contamination of Device 1 1
Tear, Rip or Hole in Device Packaging 1 1
Unintended Movement 1 1
Migration 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 13 13
Headache 12 12
No Clinical Signs, Symptoms or Conditions 9 9
No Patient Involvement 4 4
Respiratory Insufficiency 3 3
No Consequences Or Impact To Patient 3 3
Injury 3 3
Scarring 3 3
Bacterial Infection 3 3
Hemorrhage/Bleeding 3 3
No Known Impact Or Consequence To Patient 3 3
Epistaxis 2 2
Swelling/ Edema 2 2
Unspecified Infection 2 2
Inflammation 2 2
Sepsis 2 2
Therapeutic Response, Decreased 2 2
Foreign Body In Patient 2 2
Blood Loss 2 2
Airway Obstruction 1 1
Eye Pain 1 1
Skin Infection 1 1
Unspecified Tissue Injury 1 1
Hematoma 1 1
Deformity/ Disfigurement 1 1
Fungal Infection 1 1
Post Operative Wound Infection 1 1
Prolapse 1 1
Seroma 1 1
Toxic Shock Syndrome 1 1
Perforation 1 1
Respiratory Distress 1 1
Scar Tissue 1 1
Necrosis 1 1
Cellulitis 1 1
Cyst(s) 1 1
Fungus 1 1
Granuloma 1 1
No Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 GELITA MEDICAL GMBH II Sep-19-2022
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