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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device catheter, percutaneous, intraspinal, short term
Product CodeMAJ
Regulation Number 868.5120
Device Class 2

MDR Year MDR Reports MDR Events
2014 1 1
2015 3 3
2017 2 2
2018 7 7
2019 3 3
2020 5 5
2021 3 3
2022 4 4
2023 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Break 27 27
Fracture 12 12
Material Integrity Problem 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Difficult to Advance 2 2
Positioning Problem 1 1
Insufficient Information 1 1
Appropriate Term/Code Not Available 1 1
Device Or Device Fragments Location Unknown 1 1
Device Operates Differently Than Expected 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 17 17
No Known Impact Or Consequence To Patient 10 10
Device Embedded In Tissue or Plaque 2 2
Foreign Body In Patient 2 2
Inflammation 2 2
Staphylococcus Aureus 2 2
Sepsis 2 2
Headache, Lumbar Puncture 2 2
No Consequences Or Impact To Patient 1 1
Discomfort 1 1
Electric Shock 1 1
Tingling 1 1
Pain 1 1
Cerebrospinal Fluid Leakage 1 1
Unspecified Tissue Injury 1 1

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