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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
Product CodeETB
Regulation Number 874.3450
Device Class 2

MDR Year MDR Reports MDR Events
2019 6 6
2020 4 4
2021 1 1
2022 6 6
2023 1 1
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Material Deformation 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Migration 2 2
Separation Problem 1 1
Temperature Problem 1 1
Insufficient Information 1 1
Material Twisted/Bent 1 1
Break 1 1
Difficult or Delayed Positioning 1 1
Mechanical Problem 1 1
Unsealed Device Packaging 1 1
Shipping Damage or Problem 1 1
Sparking 1 1
Failure to Fire 1 1
Malposition of Device 1 1
Difficult to Open or Close 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 6 6
No Consequences Or Impact To Patient 3 3
Insufficient Information 2 2
Nerve Damage 2 2
No Known Impact Or Consequence To Patient 2 2
No Information 1 1
Partial Hearing Loss 1 1
Pain 1 1
Inadequate Pain Relief 1 1
Skin Tears 1 1
Foreign Body In Patient 1 1
Burn(s) 1 1
Facial Nerve Paralysis 1 1
Granuloma 1 1
Hearing Impairment 1 1
Inflammation 1 1

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