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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
Product CodeFZO
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2019 25 25
2020 17 17
2021 28 28
2022 18 18
2023 21 21
2024 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Break 72 72
Material Deformation 16 16
Fracture 9 9
Material Twisted/Bent 8 8
Naturally Worn 5 5
Device-Device Incompatibility 4 4
Material Fragmentation 4 4
Crack 3 3
Failure to Cut 3 3
Dull, Blunt 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Corroded 2 2
Incorrect Measurement 2 2
Peeled/Delaminated 1 1
Device Damaged Prior to Use 1 1
Difficult to Fold, Unfold or Collapse 1 1
Scratched Material 1 1
Insufficient Information 1 1
Material Split, Cut or Torn 1 1
Sharp Edges 1 1
Deformation Due to Compressive Stress 1 1
Mechanical Jam 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 72 72
No Consequences Or Impact To Patient 25 25
No Patient Involvement 7 7
No Code Available 4 4
Insufficient Information 4 4
Bone Fracture(s) 2 2
Abrasion 1 1
No Known Impact Or Consequence To Patient 1 1
Device Embedded In Tissue or Plaque 1 1
Not Applicable 1 1

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