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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device osteotome, manual
Regulation Description Manual surgical instrument for general use.
Product CodeGFI
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2016 4 4
2017 3 3
2020 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Break 6 6
No Audible Alarm 2 2
Material Integrity Problem 2 2
Fracture 1 1
Detachment Of Device Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 7 7
No Consequences Or Impact To Patient 2 2
Foreign Body In Patient 1 1

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