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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device crutch
Product CodeIPR
Regulation Number 890.3150
Device Class 1

MDR Year MDR Reports MDR Events
2014 53 53
2015 12 12
2016 9 9
2017 4 4
2018 4 4
2019 4 4
2020 5 5
2021 3 3
2022 4 4
2023 7 7
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Break 42 42
Unstable 10 10
Collapse 5 5
Detachment Of Device Component 5 5
Product Quality Problem 5 5
Device Slipped 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Disassembly 3 3
Material Disintegration 3 3
Fracture 3 3
Bent 3 3
Loose or Intermittent Connection 3 3
Crack 2 2
Torn Material 2 2
Naturally Worn 2 2
Appropriate Term/Code Not Available 2 2
Device Fell 2 2
Split 2 2
Detachment of Device or Device Component 2 2
Device Operates Differently Than Expected 2 2
Material Integrity Problem 2 2
Material Twisted/Bent 1 1
Material Deformation 1 1
Defective Device 1 1
Deformation Due to Compressive Stress 1 1
Material Separation 1 1
Material Split, Cut or Torn 1 1
Insufficient Information 1 1
Degraded 1 1
Defective Component 1 1
Out-Of-Box Failure 1 1
Device Issue 1 1
Material Frayed 1 1
Component Falling 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 40 40
Fall 28 28
Injury 12 12
No Clinical Signs, Symptoms or Conditions 5 5
Discomfort 4 4
Laceration(s) 4 4
Bone Fracture(s) 3 3
Damage to Ligament(s) 2 2
Pain 2 2
Skin Tears 2 2
No Known Impact Or Consequence To Patient 2 2
Insufficient Information 2 2
No Code Available 1 1
Muscle/Tendon Damage 1 1
Unspecified Tissue Injury 1 1
Sleep Dysfunction 1 1
No Patient Involvement 1 1
Disability 1 1
Loss of consciousness 1 1
Head Injury 1 1
Abrasion 1 1
Contusion 1 1

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