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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device osteotome, manual
Product CodeGFI
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2020 3 3
2023 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Material Integrity Problem 2 2
Break 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 3 3
Insufficient Information 1 1
No Clinical Signs, Symptoms or Conditions 1 1

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