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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


Premarket Reviews
ManufacturerDecision
ASTURA MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC SOFAMOR DANEK
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Fracture 16
Migration 8
Device Issue 4
Detachment Of Device Component 4
Material Integrity Problem 3
Break 2
Material Separation 2
Rod 2
Disconnection 1
Adverse Event Without Identified Device or Use Problem 1
Malposition of device 1
No Apparent Adverse Event 1
Mechanical Jam 1
Insufficient Information 1
Unintended Movement 1
Total Device Problems 48

Recalls
Manufacturer Recall Class Date Posted
1 OrthoPediatrics Corp II Feb-14-2018

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