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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
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 2
MEDTRONIC SOFAMOR DANEK, USA INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 28 28
2018 29 29
2019 8 8
2020 15 15
2021 7 7
2022 12 22

Device Problems MDRs with this Device Problem Events in those MDRs
Fracture 19 20
Adverse Event Without Identified Device or Use Problem 18 27
Insufficient Information 17 17
Break 12 12
Appropriate Term/Code Not Available 7 7
Malposition of Device 6 6
Cut In Material 4 4
Patient Device Interaction Problem 4 5
Migration or Expulsion of Device 3 3
Difficult to Insert 2 2
Mechanical Jam 2 2
Loosening of Implant Not Related to Bone-Ingrowth 2 2
Migration 1 1
Separation Problem 1 1
Unintended Movement 1 1
Mechanics Altered 1 1
Component or Accessory Incompatibility 1 1
Device Damaged by Another Device 1 1
Material Deformation 1 1
Material Integrity Problem 1 1
Mechanical Problem 1 1
Material Fragmentation 1 1
Misassembled 1 1
Product Quality Problem 1 1
Device Slipped 1 1
Fitting Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Information 26 26
Failure of Implant 20 22
No Clinical Signs, Symptoms or Conditions 13 21
No Code Available 10 10
Injury 10 10
Unspecified Infection 9 9
Insufficient Information 9 16
Pain 7 7
Hemothorax 5 5
No Known Impact Or Consequence To Patient 5 5
Occlusion 4 4
Collapse 4 4
Reaction 3 3
Spinal Column Injury 3 3
No Consequences Or Impact To Patient 1 1
Discomfort 1 1
Post Operative Wound Infection 1 1
Paresthesia 1 2
Device Overstimulation of Tissue 1 1
Perforation 1 1
Dyspnea 1 1
Muscle Weakness 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

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