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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device support, arm
Product CodeIOY
Regulation Number 890.3475
Device Class 1

MDR Year MDR Reports MDR Events
2014 14 14
2015 3 3
2016 12 12
2017 2 2
2018 3 3
2019 6 6
2020 16 16
2021 25 25
2022 13 13
2023 24 24
2024 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Fracture 48 48
Break 32 32
Mechanical Problem 30 30
Detachment of Device or Device Component 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Unintended Movement 2 2
Insufficient Information 1 1
Material Integrity Problem 1 1
Product Quality Problem 1 1
Material Separation 1 1
Unstable 1 1
Patient-Device Incompatibility 1 1
Component Falling 1 1
Crack 1 1
Loose or Intermittent Connection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 59 59
No Patient Involvement 29 29
No Consequences Or Impact To Patient 14 14
No Information 12 12
No Known Impact Or Consequence To Patient 3 3
Extubate 2 2
Reaction 1 1
Discomfort 1 1
Abrasion 1 1
Bruise/Contusion 1 1
Hypersensitivity/Allergic reaction 1 1
No Code Available 1 1

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