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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
Regulation Description Manual surgical instrument for general use.
Product CodeGAC
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2020 1 1
2023 3 4
2024 8 9
2025 1 1
2026 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Break 13 14
Crack 5 6
Appropriate Term/Code Not Available 5 6
Detachment of Device or Device Component 2 3
Positioning Problem 1 1
Difficult to Insert 1 1
Mechanical Problem 1 2
Activation, Positioning or Separation Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 10 12
Device Embedded In Tissue or Plaque 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Insufficient Information 1 1
No Consequences Or Impact To Patient 1 1

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