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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

Device Problems MDRs with this Device Problem Events in those MDRs
Break 75 77
Material Deformation 14 14
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 105 107
Insufficient Information 7 7
Bone Fracture(s) 3 3

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