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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


Premarket Reviews
ManufacturerDecision
ENSEMBLE ORTHOPEDICS, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 8 8
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 7 7
Insufficient Information 1 1
Positioning Failure 1 1
Nonstandard Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Injury 7 7
No Clinical Signs, Symptoms or Conditions 1 1
Pain 1 1
Unspecified Tissue Injury 1 1

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