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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)
2019 2020 2021 2022 2023 2024
1 0 0 0 0 1

MDR Year MDR Reports MDR Events
2019 12 12
2020 2 2
2021 4 4
2022 1 1
2023 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Break 10 10
Fracture 4 4
Adverse Event Without Identified Device or Use Problem 2 2
Material Split, Cut or Torn 1 1
Malposition of Device 1 1
Crack 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Loosening of Implant Not Related to Bone-Ingrowth 1 1
Use of Device Problem 1 1
Material Separation 1 1
Migration 1 1
Device Dislodged or Dislocated 1 1
Appropriate Term/Code Not Available 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Injury 6 6
Failure of Implant 4 4
No Known Impact Or Consequence To Patient 4 4
Pain 3 3
No Consequences Or Impact To Patient 2 2
Unspecified Infection 1 1
No Code Available 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Bone Fracture(s) 1 1
Insufficient Information 1 1

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