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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device prosthesis, partial ossicular replacement
Regulation Description Partial ossicular replacement prosthesis.
Product CodeETB
Regulation Number 874.3450
Device Class 2


Premarket Reviews
ManufacturerDecision
MED-EL ELEKTROMEDIZINISCHE GERÄTE GMBH
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2020 4 4
2021 1 1
2022 6 6
2023 1 1
2024 3 3
2025 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Migration 2 2
Shipping Damage or Problem 2 2
Material Deformation 2 2
Insufficient Information 1 1
Material Twisted/Bent 1 1
Difficult to Open or Close 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Separation Problem 1 1
Temperature Problem 1 1
Sparking 1 1
Mechanical Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 9 9
Insufficient Information 3 3
Inadequate Pain Relief 1 1
Hearing Impairment 1 1
Inflammation 1 1
Foreign Body In Patient 1 1
No Known Impact Or Consequence To Patient 1 1
Partial Hearing Loss 1 1
No Consequences Or Impact To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Olympus Corporation of the Americas II Aug-14-2020
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