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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 blade, saw, surgical, cardiovascular
Product CodeDWH
Regulation Number 878.4820
Device Class 1

MDR Year MDR Reports MDR Events
2017 3 3
2018 1 1
2019 1 1
2020 2 2
2021 2 2
2022 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Break 9 9
Fracture 8 8

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 5 5
No Patient Involvement 2 2
Insufficient Information 2 2

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