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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device posterior metal/polymer spinal system, fusion
Regulation Description Thoracolumbosacral pedicle screw system.
Definition This device is a posterior spinal system that contains polymer and metal components. This spinal system is to be used with bone graft and is an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine.
Product CodeNQP
Regulation Number 888.3070
Device Class 2


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

MDR Year MDR Reports MDR Events
2020 15 15
2021 7 7
2022 12 22
2023 2 2
2024 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Fracture 13 14
Adverse Event Without Identified Device or Use Problem 11 20
Patient Device Interaction Problem 5 6
Break 4 4
Loosening of Implant Not Related to Bone-Ingrowth 3 3
Appropriate Term/Code Not Available 3 3
Insufficient Information 2 2
Fitting Problem 1 1
Separation Problem 1 1
Mechanical Problem 1 1
Unintended Movement 1 1
Material Integrity Problem 1 1
Device Damaged by Another Device 1 1
Misassembled 1 1
Material Deformation 1 1
Device Handling Problem 1 1
Product Quality Problem 1 1
Detachment of Device or Device Component 1 1
No Apparent Adverse Event 1 1
Migration 1 1
Human-Device Interface Problem 1 1
Mechanical Jam 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 15 22
No Clinical Signs, Symptoms or Conditions 13 21
Failure of Implant 12 14
No Information 8 8
Spinal Column Injury 3 3
Unspecified Infection 2 2
No Code Available 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Muscle Weakness 1 1
Paresthesia 1 2
Discomfort 1 1
Pain 1 1
Nervous System Injury 1 1

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