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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device joint, ankle, external brace
Regulation Description Limb orthosis.
Product CodeITW
Regulation Number 890.3475
Device Class 1

MDR Year MDR Reports MDR Events
2020 2 2
2024 3 3
2025 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Unintended Movement 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Product Quality Problem 1 1
Fracture 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Impaired Healing 1 1
Hypersensitivity/Allergic reaction 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Blister 1 1
Numbness 1 1
Erythema 1 1
Pain 1 1
Unspecified Tissue Injury 1 1
Tissue Damage 1 1

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