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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
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
2019 136 136
2020 4 4
2021 94 94
2022 27 27
2023 4 4
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 133 133
Migration 38 38
Patient Device Interaction Problem 33 33
Break 19 19
Material Integrity Problem 15 15
Migration or Expulsion of Device 14 14
Device Slipped 4 4
No Apparent Adverse Event 4 4
Mechanical Problem 4 4
Material Twisted/Bent 3 3
Insufficient Information 1 1
Activation, Positioning or Separation Problem 1 1
Detachment of Device or Device Component 1 1
Compatibility Problem 1 1
Material Separation 1 1
Material Fragmentation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 110 110
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 36 36
Failure of Implant 35 35
Unspecified Infection 31 31
Unspecified Tissue Injury 17 17
Post Operative Wound Infection 17 17
No Clinical Signs, Symptoms or Conditions 16 16
Bone Fracture(s) 12 12
Wound Dehiscence 12 12
Pain 10 10
Impaired Healing 10 10
Non-union Bone Fracture 7 7
Paralysis 6 6
Insufficient Information 5 5
Skin Inflammation/ Irritation 4 4
Neurological Deficit/Dysfunction 4 4
Pneumonia 4 4
Pneumothorax 3 3
No Consequences Or Impact To Patient 3 3
Discomfort 3 3
Injury 3 3
Loss of Range of Motion 3 3
Skin Erosion 3 3
Physical Asymmetry 3 3
Not Applicable 3 3
Joint Laxity 2 2
Reaction 2 2
Spinal Cord Injury 2 2
Nervous System Injury 2 2
Skin Irritation 2 2
Pocket Erosion 2 2
Joint Disorder 2 2
Nerve Damage 2 2
Hematoma 2 2
Erosion 2 2
Calcium Deposits/Calcification 1 1
Cerebrospinal Fluid Leakage 1 1
Exsanguination 1 1
Foreign Body Reaction 1 1
Adhesion(s) 1 1
Adult Respiratory Distress Syndrome 1 1
Bacterial Infection 1 1
Hemorrhage/Bleeding 1 1
Ischemia 1 1
Pleural Effusion 1 1
Joint Dislocation 1 1
Osteolysis 1 1
Spinal Column Injury 1 1
Weakness 1 1
Respiratory Distress 1 1
Sepsis 1 1
Septic Shock 1 1
Seroma 1 1
No Known Impact Or Consequence To Patient 1 1
Respiratory Failure 1 1
Blood Loss 1 1
Decreased Sensitivity 1 1
Convulsion/Seizure 1 1
Unspecified Nervous System Problem 1 1
Respiratory Arrest 1 1
Vertebral Fracture 1 1

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