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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
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 22 22
Mechanical Problem 16 16
Detachment of Device or Device Component 2 2
Material Integrity Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Insufficient Information 1 1
Crack 1 1
Loose or Intermittent Connection 1 1
Product Quality Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 59 59
No Information 11 11
No Consequences Or Impact To Patient 11 11
No Patient Involvement 10 10
Discomfort 1 1
Abrasion 1 1
Bruise/Contusion 1 1

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