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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

Device Problems MDRs with this Device Problem Events in those MDRs
Patient Device Interaction Problem 67 71
Appropriate Term/Code Not Available 30 30
Loss of Osseointegration 10 12
Adverse Event Without Identified Device or Use Problem 8 8
Insufficient Information 2 4
No Apparent Adverse Event 2 2
Osseointegration Problem 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
Impaired Healing 39 39
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, Conditions Term / Code Not Available 6 6
Scar Tissue 6 6
Bacterial Infection 2 2
Hematoma 2 2
Swelling/ Edema 2 2
Insufficient Information 2 4
Tissue Breakdown 1 1

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