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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 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Break 63 63
Material Deformation 20 20
Fracture 12 12
Device-Device Incompatibility 8 8
Material Twisted/Bent 5 5
Naturally Worn 5 5
Adverse Event Without Identified Device or Use Problem 4 4
Crack 2 2
Contamination /Decontamination Problem 2 2
Failure to Cut 2 2
Incorrect Measurement 2 2
Corroded 2 2
Mechanical Jam 2 2
Device Damaged Prior to Use 1 1
Insufficient Information 1 1
Scratched Material 1 1
Sharp Edges 1 1
Detachment of Device or Device Component 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 87 87
No Consequences Or Impact To Patient 11 11
Insufficient Information 6 6
Bone Fracture(s) 4 4
No Code Available 2 2
Not Applicable 1 1
Abrasion 1 1

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