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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device prosthesis, wrist, carpal lunate
Product CodeKWN
Regulation Number 888.3750
Device Class 2

MDR Year MDR Reports MDR Events
2019 3 3
2020 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 3 3
Insufficient Information 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
Osteolysis 2 2
Post Operative Wound Infection 1 1
Hemolysis 1 1
Loss of Range of Motion 1 1

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