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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device pedicle screw spinal system, adolescent idiopathic scoliosis
Regulation Description Thoracolumbosacral pedicle screw system.
Definition Intended to stabilize the thoracolumbar spine as an adjunct to fusion using allograft and/or autograft to treat adolescent idiopathic scoliosis.
Product CodeOSH
Regulation Number 888.3070
Device Class 2

MDR Year MDR Reports MDR Events
2021 2 2
2022 8 8
2023 18 18
2024 12 12
2025 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Migration 13 13
Adverse Event Without Identified Device or Use Problem 7 7
Material Twisted/Bent 6 6
Break 5 5
Device Slipped 3 3
Material Integrity Problem 3 3
Fracture 2 2
Insufficient Information 1 1
Therapeutic or Diagnostic Output Failure 1 1
Loosening of Implant Not Related to Bone-Ingrowth 1 1
Device Dislodged or Dislocated 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 13 13
Insufficient Information 12 12
Failure of Implant 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Implant Pain 4 4
Unspecified Infection 3 3
Pain 3 3
Nerve Damage 2 2
Osteolysis 2 2
Joint Laxity 2 2
Bone Fracture(s) 1 1
Spinal Column Injury 1 1
Non-union Bone Fracture 1 1

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