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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device prosthesis, ear, internal
Product CodeFZD
Regulation Number 878.3590
Device Class 2

MDR Year MDR Reports MDR Events
2020 1 1
2021 3 3
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Fracture 2 2
Adverse Event Without Identified Device or Use Problem 1 1
Osseointegration Problem 1 1
Insufficient Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Failure of Implant 2 2
Perforation 1 1
Post Operative Wound Infection 1 1
Insufficient Information 1 1

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