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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device prosthesis, thigh socket, external component
Product CodeISS
Regulation Number 890.3420
Device Class 1

MDR Year MDR Reports MDR Events
2015 3 3
2017 3 3
2021 1 1
2023 2 2
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 3 3
Misassembled During Installation 2 2
Torn Material 2 2
Device Slipped 2 2
Device Operates Differently Than Expected 1 1
Loose or Intermittent Connection 1 1
Mechanical Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Fall 7 7
Bone Fracture(s) 3 3
Injury 2 2
Limb Fracture 1 1
Multiple Fractures 1 1
Laceration(s) 1 1
No Consequences Or Impact To Patient 1 1

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