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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device chisel, bone, surgical
Product CodeEML
Regulation Number 872.4565
Device Class 1

MDR Year MDR Reports MDR Events
2014 5 5
2015 7 7
2016 2 2
2018 2 2
2019 6 6
2020 2 2
2023 1 1
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Break 12 12
Component Missing 3 3
Device-Device Incompatibility 3 3
Material Integrity Problem 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Device Operates Differently Than Expected 2 2
Material Deformation 1 1
Defective Device 1 1
Contamination /Decontamination Problem 1 1
Detachment of Device or Device Component 1 1
Material Discolored 1 1
Fracture 1 1
Material Fragmentation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 7 7
No Consequences Or Impact To Patient 5 5
No Known Impact Or Consequence To Patient 5 5
No Clinical Signs, Symptoms or Conditions 4 4
No Code Available 2 2
Discomfort 2 2
Foreign Body In Patient 2 2
Blood Loss 1 1
Bone Fracture(s) 1 1

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