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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
2021 3 3
2022 8 8
2023 1 1
2024 16 16
2025 12 12
2026 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Patient Device Interaction Problem 24 24
Adverse Event Without Identified Device or Use Problem 13 13
Insufficient Device Problem Information 5 5
Material Twisted/Bent 1 1
Sharp Edges 1 1
Use of Device Problem 1 1
Detachment of Device or Device Component 1 1
Mechanical Problem 1 1
Inadequate Instructions for Non-Healthcare Professional 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Ulcer 17 17
Abrasion 9 9
Tissue Breakdown 6 6
Pressure Sore/Ulcer 4 4
Neuropathy 4 4
Unspecified Tissue Injury 3 3
Fall 3 3
No Clinical Signs, Symptoms or Conditions 3 3
Unspecified Infection 2 2
Bone Fracture(s) 2 2
Insufficient Information 2 2
Laceration(s) 2 2
Pain 2 2
Muscle/Tendon Damage 2 2
Multiple Fractures 1 1
Thrombosis/Thrombus 1 1
Limb Pain 1 1
Sleep Dysfunction 1 1
Limb Fracture 1 1

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