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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

MDR Year MDR Reports MDR Events
2019 4 4
2021 2 2
2022 8 8
2023 4 4
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Fracture 12 12
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
Patient Device Interaction Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 14 14
Insufficient Information 2 2
Bone Fracture(s) 2 2
Damage to Ligament(s) 1 1
Uterine Perforation 1 1
No Consequences Or Impact To Patient 1 1

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