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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device prosthesis, nose, internal
Regulation Description Nose prosthesis.
Product CodeFZE
Regulation Number 878.3680
Device Class 2


Premarket Reviews
ManufacturerDecision
CMF MEDICON SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 32 32
2022 30 30
2023 14 14
2024 26 32
2025 13 13
2026 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Patient Device Interaction Problem 71 75
Appropriate Device Problem Term/Code Not Available 30 30
Loss of Osseointegration 10 12
Adverse Event Without Identified Device or Use Problem 8 8
No Apparent Adverse Event 2 2
Insufficient Device Problem Information 2 4
Osseointegration Problem 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
Impaired Healing 41 41
Skin Infection 35 41
Unspecified Infection 18 18
Skin Inflammation/ Irritation 14 14
Inadequate Osseointegration 12 14
No Clinical Signs, Symptoms or Conditions 11 11
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 8 8
Scar Tissue 6 6
Insufficient Information 2 4
Swelling/ Edema 2 2
Hematoma 2 2
Bacterial Infection 2 2
Tissue Breakdown 1 1

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