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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device crutch
Regulation Description Crutch.
Product CodeIPR
Regulation Number 890.3150
Device Class 1

Device Problems
Break 5
Disassembly 3
Device Operates Differently Than Expected 2
Fracture 2
Adverse Event Without Identified Device or Use Problem 2
Collapse 1
Unstable 1
Detachment of Device or device Component 1
Device Slipped 1
Defective Device 1
Material Deformation 1
Material Twisted / Bent 1
Device Issue 1
Material Integrity Problem 1
Total Device Problems 23


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