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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
2020 17 17
2021 28 28
2022 18 18
2023 21 21
2024 19 19
2025 16 16

Device Problems MDRs with this Device Problem Events in those MDRs
Break 71 71
Material Deformation 20 20
Fracture 13 13
Device-Device Incompatibility 8 8
Crack 6 6
Material Twisted/Bent 5 5
Naturally Worn 5 5
Adverse Event Without Identified Device or Use Problem 4 4
Incorrect Measurement 3 3
Corroded 2 2
Mechanical Jam 2 2
Failure to Cut 2 2
Contamination /Decontamination Problem 2 2
Device Damaged Prior to Use 1 1
Dull, Blunt 1 1
Scratched Material 1 1
Insufficient Information 1 1
Sharp Edges 1 1
Deformation Due to Compressive Stress 1 1
Detachment of Device or Device Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 96 96
No Consequences Or Impact To Patient 11 11
Insufficient Information 8 8
Bone Fracture(s) 4 4
No Code Available 2 2
Abrasion 1 1
Not Applicable 1 1

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