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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
Product CodeKNP
Regulation Number 890.3475
Device Class 1

MDR Year MDR Reports MDR Events
2019 20 20
2020 6 6
2021 3 3
2022 8 8
2023 1 1
2024 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 17 17
Insufficient Information 8 8
Patient Device Interaction Problem 5 5
Break 4 4
Device Contaminated During Manufacture or Shipping 2 2
Device Slipped 1 1
Unstable 1 1
Use of Device Problem 1 1
Sharp Edges 1 1
Product Quality Problem 1 1
Inadequacy of Device Shape and/or Size 1 1
Loose or Intermittent Connection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pressure Sores 7 7
Ulcer 6 6
Unspecified Infection 5 5
Bone Fracture(s) 4 4
Fall 4 4
Injury 3 3
Unspecified Tissue Injury 3 3
Neuropathy 2 2
Head Injury 2 2
Sleep Dysfunction 1 1
Abrasion 1 1
No Known Impact Or Consequence To Patient 1 1
Burn(s) 1 1
Thrombosis/Thrombus 1 1
Swelling 1 1
Discomfort 1 1
Skin Inflammation 1 1
Insufficient Information 1 1
Laceration(s) 1 1
Pain 1 1
Limb Fracture 1 1
Muscle/Tendon Damage 1 1
Erosion 1 1
Tissue Breakdown 1 1

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