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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
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 25 25
Fracture 12 12
Adverse Event Without Identified Device or Use Problem 3 3
Material Integrity Problem 2 2
Difficult to Advance 1 1
Positioning Problem 1 1
Insufficient Information 1 1
Appropriate Term/Code Not Available 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 9 9
Foreign Body In Patient 2 2
Inflammation 2 2
Staphylococcus Aureus 2 2
Sepsis 2 2
Headache, Lumbar Puncture 1 1
Cerebrospinal Fluid Leakage 1 1
Device Embedded In Tissue or Plaque 1 1
Unspecified Tissue Injury 1 1

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