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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
Regulation Description Finger joint polymer constrained prosthesis.
Product CodeKWF
Regulation Number 888.3230
Device Class 2

MDR Year MDR Reports MDR Events
2016 2 2
2018 23 23
2019 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Fracture 17 17
Adverse Event Without Identified Device or Use Problem 6 6
Break 4 4
Migration 2 2
Material Rupture 1 1
Insufficient Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 22 22
Pain 3 3
Joint Dislocation 1 1
Reaction 1 1
Patient Problem/Medical Problem 1 1
Ossification 1 1
Failure of Implant 1 1
Unspecified Infection 1 1

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