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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


Premarket Reviews
ManufacturerDecision
ARTHROSURFACE, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 1 1
2017 1 1
2018 2 2
2019 3 3
2020 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 4 4
Adverse Event Without Identified Device or Use Problem 3 3
Migration or Expulsion of Device 2 2
Inadequacy of Device Shape and/or Size 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 3 3
Osteolysis 2 2
Post Operative Wound Infection 1 1
No Information 1 1
Hemolysis 1 1
Unspecified Infection 1 1
Nerve Damage 1 1
Loss of Range of Motion 1 1
Swelling 1 1
Weakness 1 1
Burning Sensation 1 1
Tingling 1 1

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