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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device prosthesis, wrist, 2 part metal-plastic articulation, semi-constrained
Product CodeJWI
Regulation Number 888.3800
Device Class 2

MDR Year MDR Reports MDR Events
2019 2 2
2022 1 1
2023 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Device Dislodged or Dislocated 2 2
Adverse Event Without Identified Device or Use Problem 1 1
Material Discolored 1 1
Fracture 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Joint Dislocation 2 2
Insufficient Information 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Foreign Body Reaction 1 1
Hypersensitivity/Allergic reaction 1 1
Unspecified Infection 1 1

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