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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

MDR Year MDR Reports MDR Events
2015 3 3
2016 9 9
2017 4 4
2018 14 14
2019 12 12
2020 10 10

Device Problems MDRs with this Device Problem Events in those MDRs
Fracture 21 21
Break 11 11
Migration 5 5
Detachment Of Device Component 4 4
Screw 4 4
Device Issue 4 4
Material Integrity Problem 3 3
Detachment of Device or Device Component 2 2
Naturally Worn 2 2
Rod 2 2
Material Separation 2 2
Use of Device Problem 1 1
Mechanical Problem 1 1
Disconnection 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Unintended Movement 1 1
No Apparent Adverse Event 1 1
Insufficient Information 1 1
Device Operates Differently Than Expected 1 1
Device Dislodged or Dislocated 1 1
Malposition of Device 1 1
Mechanical Jam 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 16 16
Congenital Defect/Deformity 11 11
No Information 10 10
Pain 7 7
Injury 6 6
Failure of Implant 3 3
No Consequences Or Impact To Patient 2 2
No Code Available 2 2
Neurological Deficit/Dysfunction 1 1
Reaction 1 1
Post Operative Wound Infection 1 1
Device Embedded In Tissue or Plaque 1 1

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