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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device vertebral body tethering system
Definition Anterior-based stabilization or correction of juvenile or adolescent idiopathic scoliosis without the use of fusion
Product CodeQHP
Device Class Not Classified

MDR Year MDR Reports MDR Events
2021 102 102
2022 25 25
2023 44 77
2024 41 41
2025 22 22
2026 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 102 124
Unintended Movement 48 51
Mechanical Problem 24 28
Break 15 15
Fracture 14 18
Retraction Problem 9 9
Loosening of Implant Not Related to Bone-Ingrowth 7 7
Insufficient Information 5 5
Migration 3 3
Material Deformation 2 2
Device-Device Incompatibility 1 1
Malposition of Device 1 1
Output Problem 1 1
Use of Device Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Spinal Column Injury 59 59
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 48 64
Insufficient Information 42 59
No Clinical Signs, Symptoms or Conditions 20 20
Loss of Range of Motion 20 20
Hemorrhage/Bleeding 19 19
Failure of Implant 10 10
Deformity/ Disfigurement 9 9
Spinal Cord Injury 8 8
Pain 4 4
Aspiration/Inhalation 1 1
Unspecified Nervous System Problem 1 1
Scar Tissue 1 1
Pneumonia 1 1
Unspecified Tissue Injury 1 1
Intervertebral Disc Compression or Protrusion 1 1

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