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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device orthosis, corrective shoe
Regulation Description Limb orthosis.
Product CodeKNP
Regulation Number 890.3475
Device Class 1

MDR Year MDR Reports MDR Events
2020 6 6
2021 3 3
2022 8 8
2023 1 1
2024 16 16
2025 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 18 18
Patient Device Interaction Problem 11 11
Insufficient Information 5 5
Break 2 2
Detachment of Device or Device Component 1 1
Inadequacy of Device Shape and/or Size 1 1
Mechanical Problem 1 1
Use of Device Problem 1 1
Material Twisted/Bent 1 1
Loose or Intermittent Connection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Ulcer 10 10
Pressure Sores 7 7
Tissue Breakdown 6 6
Neuropathy 4 4
Abrasion 4 4
Unspecified Tissue Injury 3 3
Laceration(s) 2 2
Pain 2 2
Fall 2 2
Bone Fracture(s) 2 2
Unspecified Infection 2 2
Insufficient Information 2 2
Injury 2 2
Thrombosis/Thrombus 1 1
Limb Fracture 1 1
Muscle/Tendon Damage 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Skin Inflammation 1 1
Sleep Dysfunction 1 1

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