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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
Product CodeITW
Regulation Number 890.3475
Device Class 1

MDR Year MDR Reports MDR Events
2018 12 12
2019 8 8
2020 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 9 9
Patient Device Interaction Problem 3 3
Inadequacy of Device Shape and/or Size 2 2
Unstable 2 2
Malposition of Device 2 2
Patient-Device Incompatibility 1 1
Break 1 1
Collapse 1 1
Crack 1 1
Material Separation 1 1
Unintended Movement 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Tissue Damage 4 4
Swelling 2 2
Thrombosis 2 2
Injury 2 2
Patient Problem/Medical Problem 2 2
No Information 2 2
No Code Available 1 1
Impaired Healing 1 1
Post Operative Wound Infection 1 1
Pressure Sores 1 1
Bruise/Contusion 1 1
Fall 1 1
Fungus 1 1
Laceration(s) 1 1

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