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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 trapezium
Regulation Description Wrist joint carpal trapezium polymer prosthesis.
Product CodeKYI
Regulation Number 888.3770
Device Class 2

MDR Year MDR Reports MDR Events
2024 1 1
2026 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Positioning Failure 1 1
Insufficient Device Problem Information 1 1
Nonstandard Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Implant Pain 2 2
Limb Pain 2 2
Joint Laxity 1 1
Device Overstimulation of Tissue 1 1
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 1 1
Failure of Implant 1 1
Unspecified Tissue Injury 1 1
Inadequate Osseointegration 1 1
Loss of Range of Motion 1 1
Joint Dislocation 1 1
Pocket Erosion 1 1
No Clinical Signs, Symptoms or Conditions 1 1

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