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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device prosthesis, rib replacement
Regulation Description Thoracolumbosacral pedicle screw system.
Definition In children with or at risk of developing Thoracic Insufficiency Syndrome, the expandable rib prosthesis devices mechanically stabilize and/or correct thoracic deformities to allow the chest and lungs to grow. The devices are attached perpendicularly to the subject's natural ribs and lumbar vertebra or pelvis. This mechanically stabilizes the chest wall and enlarges the thorax to improve respiration and lung growth. The devices allow assembly in a number of different configurations to accommodate the wide variety of anatomical deformities encountered by the clinician in treating patients with or at risk of developing Thoracic Insufficiency Syndrome.
Product CodeMDI
Regulation Number 888.3070
Device Class 2


Premarket Reviews
ManufacturerDecision
ORTHOPEDIATRICS CORP.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 4 4
2021 94 94
2022 27 27
2023 4 4
2024 20 20

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 80 80
Patient Device Interaction Problem 39 39
Material Integrity Problem 17 17
Mechanical Problem 6 6
Material Twisted/Bent 3 3
Break 3 3
Compatibility Problem 1 1
Insufficient Information 1 1
Material Separation 1 1
Device Slipped 1 1
Activation, Positioning or Separation Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 37 37
Failure of Implant 21 21
Post Operative Wound Infection 18 18
Unspecified Tissue Injury 18 18
No Clinical Signs, Symptoms or Conditions 16 16
Insufficient Information 16 16
Unspecified Infection 12 12
Impaired Healing 9 9
Pain 7 7
Non-union Bone Fracture 7 7
Wound Dehiscence 6 6
Skin Inflammation/ Irritation 4 4
Paralysis 3 3
Pneumonia 3 3
Not Applicable 3 3
Physical Asymmetry 3 3
Unspecified Nervous System Problem 2 2
Pneumothorax 2 2
Nervous System Injury 2 2
Skin Erosion 2 2
No Consequences Or Impact To Patient 2 2
Joint Laxity 2 2
Bone Fracture(s) 2 2
Hematoma 2 2
Respiratory Arrest 1 1
Convulsion/Seizure 1 1
No Code Available 1 1
Decreased Sensitivity 1 1
Metal Related Pathology 1 1
Vertebral Fracture 1 1
Hemorrhage/Bleeding 1 1
Exsanguination 1 1
Cerebrospinal Fluid Leakage 1 1
Bacterial Infection 1 1
Adult Respiratory Distress Syndrome 1 1
Adhesion(s) 1 1
Respiratory Failure 1 1
Spinal Cord Injury 1 1
Osteolysis 1 1
Seroma 1 1
Septic Shock 1 1
Loss of Range of Motion 1 1
Pocket Erosion 1 1
Pleural Effusion 1 1
Nerve Damage 1 1
Ischemia 1 1

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