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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device intervertebral fusion device with bone graft, thoracic
Definition Intended to stabilize thoracic spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.
Product CodePHM
Regulation Number 888.3080
Device Class 2


Premarket Reviews
ManufacturerDecision
ALPHATEC SPINE
  SUBSTANTIALLY EQUIVALENT 1
ALPHATEC SPINE, INC
  SUBSTANTIALLY EQUIVALENT 1
NUVASIVE, INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 1 1
2018 1 1
2019 4 4
2021 2 2
2022 8 8
2023 4 4
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Fracture 11 11
Adverse Event Without Identified Device or Use Problem 3 3
Material Deformation 2 2
Migration or Expulsion of Device 2 2
Migration 2 2
Misconnection 1 1
Material Separation 1 1
Malposition of Device 1 1
Detachment of Device or Device Component 1 1
Device Damaged by Another Device 1 1
Break 1 1
Unintended Movement 1 1
Patient Device Interaction Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 13 13
Insufficient Information 2 2
Bone Fracture(s) 2 2
Failure of Implant 1 1
Paresis 1 1
Uterine Perforation 1 1
No Consequences Or Impact To Patient 1 1

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