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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
2020 23 23
2021 32 32
2022 30 30
2023 14 14
2024 26 26
2025 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Patient Device Interaction Problem 66 66
Appropriate Term/Code Not Available 37 37
Adverse Event Without Identified Device or Use Problem 15 15
Loss of Osseointegration 15 15
Insufficient Information 2 2
Osseointegration Problem 2 2
No Apparent Adverse Event 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
Impaired Healing 35 35
Skin Infection 32 32
Unspecified Infection 25 25
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 16 16
Skin Inflammation/ Irritation 12 12
Inadequate Osseointegration 12 12
No Clinical Signs, Symptoms or Conditions 11 11
Scar Tissue 6 6
No Code Available 3 3
Host-Tissue Reaction 2 2
Bacterial Infection 2 2
Hematoma 2 2
Swelling/ Edema 2 2
Insufficient Information 2 2
Abscess 1 1
Head Injury 1 1
Tissue Breakdown 1 1

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