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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device replacement, ossicular prosthesis, total
Regulation Description Total ossicular replacement prosthesis.
Product CodeETA
Regulation Number 874.3495
Device Class 2


Premarket Reviews
ManufacturerDecision
MED-EL ELEKTROMEDIZINISCHE GERÄTE GMBH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 1 1
2022 4 4
2023 5 5
2024 8 8
2025 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Break 12 12
Adverse Event Without Identified Device or Use Problem 2 2
Material Protrusion/Extrusion 2 2
Migration or Expulsion of Device 1 1
Use of Device Problem 1 1
Detachment of Device or Device Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 12 12
Failure of Implant 3 3
Hearing Impairment 1 1
Perforation 1 1
Implant Pain 1 1
Unspecified Ear or Labyrinth Problem 1 1
No Consequences Or Impact To Patient 1 1

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