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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 scaphoid
Product CodeKWO
Regulation Number 888.3760
Device Class 2

MDR Year MDR Reports MDR Events
2016 2 2
2019 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Migration or Expulsion of Device 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Unintended Movement 1 1
Insufficient Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 3 3
Failure of Implant 1 1
Nerve Damage 1 1
Pain 1 1
Non-union Bone Fracture 1 1

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