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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 INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2016 79 79
2017 28 28
2018 29 29
2019 8 8
2020 15 15
2021 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 36 36
Loose or Intermittent Connection 30 30
Break 24 24
Fracture 15 15
Device Slipped 13 13
Adverse Event Without Identified Device or Use Problem 13 13
Appropriate Term/Code Not Available 9 9
Malposition of Device 6 6
Migration or Expulsion of Device 5 5
Cut In Material 4 4
Patient Device Interaction Problem 2 2
Loosening of Implant Not Related to Bone-Ingrowth 2 2
Device-Device Incompatibility 2 2
Difficult to Insert 2 2
Partial Blockage 1 1
Mechanics Altered 1 1
Misassembled 1 1
Product Quality Problem 1 1
Fitting Problem 1 1
Migration 1 1
Collapse 1 1
Microbial Contamination of Device 1 1
Material Fragmentation 1 1
Failure to Align 1 1
Component or Accessory Incompatibility 1 1
Device Operates Differently Than Expected 1 1
Device Damaged by Another Device 1 1
Mechanical Jam 1 1
No Apparent Adverse Event 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Information 51 51
No Code Available 36 36
Failure of Implant 18 18
Unspecified Infection 15 15
Injury 15 15
No Known Impact Or Consequence To Patient 14 14
Pain 10 10
Hemothorax 5 5
No Clinical Signs, Symptoms or Conditions 5 5
Collapse 4 4
Occlusion 4 4
Complaint, Ill-Defined 3 3
Reaction 3 3
Spinal Column Injury 2 2
Therapeutic Effects, Unexpected 1 1
No Consequences Or Impact To Patient 1 1
Device Overstimulation of Tissue 1 1
Perforation 1 1
Neurological Deficit/Dysfunction 1 1
Dyspnea 1 1
Hematoma 1 1
Spinal Cord Injury 1 1
Insufficient Information 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Post Operative Wound Infection 1 1
Paralysis 1 1
Weakness 1 1
Discomfort 1 1

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