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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
2019 8 8
2020 15 15
2021 7 7
2022 12 22
2023 2 2
2024 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Fracture 13 14
Adverse Event Without Identified Device or Use Problem 12 21
Insufficient Information 6 6
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
Difficult to Insert 2 2
Mechanical Problem 1 1
Misassembled 1 1
Product Quality Problem 1 1
Fitting Problem 1 1
Detachment of Device or Device Component 1 1
Device Damaged by Another Device 1 1
Human-Device Interface Problem 1 1
Material Deformation 1 1
Material Integrity Problem 1 1
Mechanical Jam 1 1
Device Handling Problem 1 1
Unintended Movement 1 1
Migration 1 1
Separation Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Failure of Implant 14 16
Insufficient Information 14 21
No Clinical Signs, Symptoms or Conditions 13 21
No Information 12 12
No Code Available 3 3
Unspecified Infection 2 2
Spinal Column Injury 2 2
No Consequences Or Impact To Patient 1 1
Discomfort 1 1
Nervous System Injury 1 1
Muscle Weakness 1 1
Pain 1 1
Paresthesia 1 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

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