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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
2018 66 66
2019 25 25
2020 17 17
2021 28 28
2022 18 18
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Break 105 105
Material Deformation 18 18
Fracture 9 9
Material Twisted/Bent 7 7
Dull, Blunt 5 5
Material Fragmentation 5 5
Crack 3 3
Failure to Cut 3 3
Adverse Event Without Identified Device or Use Problem 2 2
Corroded 2 2
Incorrect Measurement 2 2
Insufficient Information 2 2
Material Split, Cut or Torn 1 1
Sharp Edges 1 1
Peeled/Delaminated 1 1
Device Damaged Prior to Use 1 1
Defective Component 1 1
Difficult to Fold, Unfold or Collapse 1 1
Scratched Material 1 1
Device-Device Incompatibility 1 1
Mechanical Jam 1 1
Naturally Worn 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 49 49
No Clinical Signs, Symptoms or Conditions 47 47
No Consequences Or Impact To Patient 37 37
No Known Impact Or Consequence To Patient 10 10
Bone Fracture(s) 4 4
No Code Available 4 4
Insufficient Information 3 3
Abrasion 1 1
Device Embedded In Tissue or Plaque 1 1
Not Applicable 1 1
No Information 1 1

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