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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device facial implant
Regulation Description Polytetrafluoroethylene with carbon fibers composite implant material.
Definition For use in plastic and reconstructive surgery. The devices can be used for cosmetic augmentation and corrections of soft tissue deformities in the face, including areas such as the nose, chin, and cheeks.
Product CodeODU
Regulation Number 878.3500
Device Class 2

MDR Year MDR Reports MDR Events
2021 2 3
2022 3 3
2023 2 2
2026 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Deformation Due to Compressive Stress 3 3
Break 2 2
Fracture 1 1
Patient Device Interaction Problem 1 1
Connection Problem 1 1
Loss of Osseointegration 1 2
Migration 1 1
Migration or Expulsion of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 4 5
Failure of Implant 3 3
Inadequate Osseointegration 2 2
Insufficient Information 1 2

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