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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
2020 38 38
2021 102 102
2022 25 25
2023 11 11
2024 9 9

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 114 114
Unintended Movement 29 29
Mechanical Problem 21 21
Loosening of Implant Not Related to Bone-Ingrowth 7 7
Break 4 4
Fracture 3 3
Material Deformation 2 2
Output Problem 1 1
Use of Device Problem 1 1
Malposition of Device 1 1
Device-Device Incompatibility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 53 53
Spinal Column Injury 30 30
Pain 22 22
Pleural Effusion 21 21
Hemothorax 21 21
Syncope 21 21
Anemia 21 21
Chest Pain 21 21
Syncope/Fainting 21 21
Loss of Range of Motion 20 20
Hemorrhage/Bleeding 19 19
No Code Available 17 17
Insufficient Information 16 16
No Clinical Signs, Symptoms or Conditions 16 16
Cerebrospinal Fluid Leakage 15 15
Failure of Implant 8 8
Deformity/ Disfigurement 8 8
Unspecified Nervous System Problem 1 1
Unspecified Tissue Injury 1 1

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