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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 44 44
2024 33 33

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 138 138
Unintended Movement 42 42
Mechanical Problem 25 25
Break 12 12
Fracture 7 7
Loosening of Implant Not Related to Bone-Ingrowth 7 7
Insufficient Information 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
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 69 69
Spinal Column Injury 43 43
Insufficient Information 38 38
Pain 24 24
Syncope/Fainting 21 21
Syncope 21 21
Anemia 21 21
Chest Pain 21 21
Pleural Effusion 21 21
Hemothorax 21 21
Loss of Range of Motion 20 20
Hemorrhage/Bleeding 19 19
No Code Available 17 17
No Clinical Signs, Symptoms or Conditions 16 16
Cerebrospinal Fluid Leakage 15 15
Failure of Implant 10 10
Deformity/ Disfigurement 9 9
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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