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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device prosthesis, finger, polymer
Product CodeKWF
Regulation Number 888.3230
Device Class 2

MDR Year MDR Reports MDR Events
2014 3 3
2016 2 2
2018 23 23
2019 5 5
2020 2 2
2021 2 2
2022 5 5
2023 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Fracture 21 21
Adverse Event Without Identified Device or Use Problem 11 11
Break 7 7
Unstable 5 5
Migration 2 2
Device Operates Differently Than Expected 1 1
Human-Device Interface Problem 1 1
Unintended Movement 1 1
Insufficient Information 1 1
Entrapment of Device 1 1
Material Rupture 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 23 23
Pain 5 5
Loss of Range of Motion 5 5
Osteopenia/ Osteoporosis 5 5
Arthritis 2 2
Failure of Implant 2 2
Unspecified Infection 1 1
Patient Problem/Medical Problem 1 1
No Consequences Or Impact To Patient 1 1
Joint Dislocation 1 1
Reaction 1 1
No Code Available 1 1
Implant Pain 1 1
Swelling/ Edema 1 1
Ossification 1 1

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