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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device replacement, ossicular prosthesis, total
Product CodeETA
Regulation Number 874.3495
Device Class 2

MDR Year MDR Reports MDR Events
2019 9 9
2020 1 1
2022 4 4
2023 5 5
2024 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Break 17 17
Material Separation 4 4
Adverse Event Without Identified Device or Use Problem 2 2
Migration or Expulsion of Device 1 1
Use of Device Problem 1 1
Detachment of Device or Device Component 1 1
Material Protrusion/Extrusion 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 12 12
No Consequences Or Impact To Patient 7 7
Failure of Implant 4 4
Hearing Impairment 2 2
Hearing Loss 1 1
Perforation 1 1
Foreign Body In Patient 1 1
No Known Impact Or Consequence To Patient 1 1
Unspecified Ear or Labyrinth Problem 1 1
Implant Pain 1 1

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