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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
Regulation Description Intervertebral body fusion device.
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
2021 2 2
2022 8 8
2023 4 4
2024 3 3
2025 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Fracture 13 13
Material Deformation 2 2
Migration 2 2
Break 1 1
Migration or Expulsion of Device 1 1
Malposition of Device 1 1
Patient Device Interaction Problem 1 1
Device Damaged by Another Device 1 1
Misconnection 1 1
Material Separation 1 1
Detachment of Device or Device Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 15 15
Insufficient Information 2 2
Damage to Ligament(s) 1 1

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