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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device instrument, shunt system implantation
Regulation Description Shunt system implantation instrument.
Product CodeGYK
Regulation Number 882.4545
Device Class 1

MDR Year MDR Reports MDR Events
2016 2 2
2017 1 1
2020 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Break 2 2
Defective Device 1 1
Device Or Device Fragments Location Unknown 1 1
Device Operates Differently Than Expected 1 1
Device Packaging Compromised 1 1
Patient Device Interaction Problem 1 1
Bent 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 1 1
Device Embedded In Tissue or Plaque 1 1
Not Applicable 1 1
No Information 1 1

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