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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

MDR Year MDR Reports MDR Events
2016 9 9
2017 4 4
2018 4 4
2019 4 4
2020 5 5
2021 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Break 14 14
Collapse 2 2
Disassembly 2 2
Loose or Intermittent Connection 2 2
Defective Component 1 1
Material Integrity Problem 1 1
Device Fell 1 1
Fracture 1 1
Device Issue 1 1
Split 1 1
Defective Device 1 1
Detachment of Device or Device Component 1 1
Device Operates Differently Than Expected 1 1
Material Twisted/Bent 1 1
Torn Material 1 1
Tip 1 1
Screw 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Fall 14 14
Injury 6 6
Laceration(s) 2 2
No Clinical Signs, Symptoms or Conditions 2 2
No Known Impact Or Consequence To Patient 1 1
Pain 1 1
Contusion 1 1
Bone Fracture(s) 1 1
Head Injury 1 1
Disability 1 1
No Code Available 1 1
Unspecified Tissue Injury 1 1

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