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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
ARTHROCARE CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
BIOMED ENT, INC.
  SUBSTANTIALLY EQUIVALENT 1
CHITOGEL LTD
  SUBSTANTIALLY EQUIVALENT 1
COGENT THERAPEUTICS, LLC
  SUBSTANTIALLY EQUIVALENT 1
ENTRIGUE SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
GYRUS ACMI, INC
  SUBSTANTIALLY EQUIVALENT 1
HEMOSTASIS, LLC
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC XOMED
  SUBSTANTIALLY EQUIVALENT 1
POLYGANICS BV
  SUBSTANTIALLY EQUIVALENT 2
SINEXUS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SPIWAY LLC
  SUBSTANTIALLY EQUIVALENT 2
SPIWAY, LLC
  SUBSTANTIALLY EQUIVALENT 2
STS MEDICAL
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 4 4
2015 28 28
2016 28 28
2017 10 10
2018 19 19
2019 5 5
2020 6 6
2021 19 19
2022 8 8
2023 17 17
2024 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 37 37
Device Operates Differently Than Expected 23 23
Material Integrity Problem 14 14
Packaging Problem 14 14
Insufficient Information 10 10
Patient-Device Incompatibility 8 8
Tear, Rip or Hole in Device Packaging 5 5
Device Contamination with Chemical or Other Material 4 4
Appropriate Term/Code Not Available 3 3
Device Dislodged or Dislocated 3 3
Migration or Expulsion of Device 3 3
Material Fragmentation 3 3
Use of Device Problem 3 3
Unexpected Therapeutic Results 2 2
Contamination of Device Ingredient or Reagent 2 2
Device Emits Odor 2 2
Activation Failure 2 2
Residue After Decontamination 2 2
Material Too Rigid or Stiff 2 2
Microbial Contamination of Device 2 2
Device Ingredient or Reagent Problem 2 2
Improper or Incorrect Procedure or Method 2 2
Material Discolored 1 1
Obstruction of Flow 1 1
Difficult to Insert 1 1
Improper Chemical Reaction 1 1
Contamination /Decontamination Problem 1 1
Unintended Movement 1 1
Material Disintegration 1 1
Difficult to Remove 1 1
Inadequacy of Device Shape and/or Size 1 1
Unsealed Device Packaging 1 1
Incomplete or Missing Packaging 1 1
Material Frayed 1 1
Migration 1 1
Labelling, Instructions for Use or Training Problem 1 1
Over-Sensing 1 1
Nonstandard Device 1 1
Coagulation in Device or Device Ingredient 1 1
Melted 1 1
Component Falling 1 1
High Capture Threshold 1 1
Biocompatibility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 17 17
Headache 17 17
Pain 16 16
Unspecified Infection 12 12
Inflammation 10 10
No Code Available 8 8
No Patient Involvement 8 8
Hemorrhage/Bleeding 8 8
No Known Impact Or Consequence To Patient 8 8
Reaction 7 7
Swelling/ Edema 6 6
Pneumonia 5 5
No Consequences Or Impact To Patient 5 5
Complaint, Ill-Defined 4 4
Bacterial Infection 4 4
Post Traumatic Wound Infection 4 4
Low Oxygen Saturation 3 3
Nausea 3 3
Sepsis 3 3
Respiratory Insufficiency 3 3
Injury 3 3
Adhesion(s) 3 3
Unspecified Tissue Injury 3 3
Scarring 3 3
Seroma 3 3
Swelling 2 2
Foreign Body In Patient 2 2
Therapeutic Response, Decreased 2 2
Epistaxis 2 2
Post Operative Wound Infection 2 2
Staphylococcus Aureus 2 2
Blood Loss 2 2
Respiratory Distress 2 2
Loss of Vision 1 1
Toxic Shock Syndrome 1 1
Deformity/ Disfigurement 1 1
Eye Pain 1 1
Loss of consciousness 1 1
Airway Obstruction 1 1
Increased Respiratory Rate 1 1
Anxiety 1 1
Host-Tissue Reaction 1 1
Failure to Anastomose 1 1
Granuloma 1 1
Device Embedded In Tissue or Plaque 1 1
Intraocular Infection 1 1
Nasal Obstruction 1 1
Fall 1 1
Prolapse 1 1
Scar Tissue 1 1

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