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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

Device Problems MDRs with this Device Problem Events in those MDRs
Break 9 9
Material Separation 4 4
Migration or Expulsion of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 7 7
No Clinical Signs, Symptoms or Conditions 3 3
Failure of Implant 2 2
Hearing Impairment 1 1
No Known Impact Or Consequence To Patient 1 1
Hearing Loss 1 1
Unspecified Ear or Labyrinth Problem 1 1
Foreign Body In Patient 1 1

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