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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device chisel, surgical, manual
Regulation Description Manual surgical instrument for general use.
Product CodeFZO
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2021 28 28
2022 18 20
2023 21 21
2024 19 19
2025 27 27
2026 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Break 79 81
Material Deformation 15 15
Fracture 13 13
Device-Device Incompatibility 7 7
Crack 6 6
Naturally Worn 5 5
Material Twisted/Bent 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Incorrect Measurement 3 3
Contamination /Decontamination Problem 2 2
Failure to Cut 2 2
Corroded 2 2
Mechanical Jam 2 2
Device Damaged Prior to Use 1 1
Scratched Material 1 1
Sharp Edges 1 1
Detachment of Device or Device Component 1 1
No Apparent Adverse Event 1 1
Deformation Due to Compressive Stress 1 1
Dull, Blunt 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 110 112
Insufficient Information 7 7
Bone Fracture(s) 3 3

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