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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device finger semi-constrained pyrolytic carbon uncemented prosthesis
Definition Pma approved: P000057
Product CodeNEG
Device Class 3

Premarket Approvals (PMA)
2021 2022 2023 2024 2025 2026
0 0 0 1 2 0

MDR Year MDR Reports MDR Events
2021 4 4
2022 1 1
2023 2 2
2024 1 1
2025 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Break 4 4
Fracture 4 4
Malposition of Device 1 1
Insufficient Information 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Migration 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Failure of Implant 5 5
Insufficient Information 2 2
Joint Dislocation 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Pain 1 1

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