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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device rasp, surgical, general & plastic surgery
Product CodeGAC
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2019 3 3
2020 1 1
2023 3 3
2024 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Break 11 11
Detachment of Device or Device Component 1 1
Mechanical Problem 1 1
Positioning Problem 1 1
Difficult to Insert 1 1
Activation, Positioning or Separation Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 9 9
No Consequences Or Impact To Patient 4 4

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