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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device table, operating-room, mechanical
Product CodeFWX
Regulation Number 878.4950
Device Class 1

MDR Year MDR Reports MDR Events
2023 2 2
2024 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Appropriate Term/Code Not Available 3 3
Adverse Event Without Identified Device or Use Problem 2 2
Insufficient Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Bone Fracture(s) 5 5
Hip Fracture 1 1

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