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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
2018 37 37
2019 136 136
2020 4 4
2021 94 94
2022 27 27
2023 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 152 152
Migration 38 38
Patient Device Interaction Problem 33 33
Break 29 29
Migration or Expulsion of Device 20 20
Material Integrity Problem 15 15
Device Slipped 5 5
Mechanical Problem 4 4
No Apparent Adverse Event 4 4
Material Twisted/Bent 3 3
Unintended Movement 1 1
Activation, Positioning or Separation Problem 1 1
Detachment of Device or Device Component 1 1
Compatibility Problem 1 1
Nonstandard Device 1 1
Material Separation 1 1
Material Fragmentation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 122 122
Failure of Implant 45 45
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 36 36
Unspecified Infection 33 33
Post Operative Wound Infection 17 17
No Clinical Signs, Symptoms or Conditions 16 16
Unspecified Tissue Injury 16 16
Bone Fracture(s) 13 13
Wound Dehiscence 13 13
Pain 12 12
Impaired Healing 10 10
Neurological Deficit/Dysfunction 9 9
Non-union Bone Fracture 7 7
Paralysis 6 6
Pneumonia 5 5
No Known Impact Or Consequence To Patient 5 5
Skin Inflammation/ Irritation 4 4
Insufficient Information 4 4
Not Applicable 3 3
Physical Asymmetry 3 3
Pneumothorax 3 3
Loss of Range of Motion 3 3
Skin Erosion 3 3
No Consequences Or Impact To Patient 3 3
Discomfort 3 3
Injury 3 3
Foreign Body Reaction 3 3
Nerve Damage 2 2
Erosion 2 2
Skin Irritation 2 2
Spinal Column Injury 2 2
Pocket Erosion 2 2
Seroma 2 2
Joint Laxity 2 2
Joint Disorder 2 2
Reaction 2 2
Spinal Cord Injury 2 2
Foreign Body In Patient 2 2
Nervous System Injury 2 2
Convulsion/Seizure 1 1
Unspecified Nervous System Problem 1 1
Respiratory Arrest 1 1
Vertebral Fracture 1 1
Joint Dislocation 1 1
Osteolysis 1 1
Respiratory Failure 1 1
Blood Loss 1 1
Decreased Sensitivity 1 1
Respiratory Distress 1 1
Sepsis 1 1
Septic Shock 1 1
Weakness 1 1
Ulcer 1 1
Calcium Deposits/Calcification 1 1
Cerebrospinal Fluid Leakage 1 1
Exsanguination 1 1
Adhesion(s) 1 1
Adult Respiratory Distress Syndrome 1 1
Bacterial Infection 1 1
Pleural Effusion 1 1
Hematoma 1 1
Hemorrhage/Bleeding 1 1
Ischemia 1 1

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