• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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
Compatibility Problem 1 1
Activation, Positioning or Separation Problem 1 1
Nonstandard Device 1 1
Detachment of Device or Device Component 1 1
Material Separation 1 1
Material Fragmentation 1 1
Unintended Movement 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
Insufficient Information 4 4
Skin Inflammation/ Irritation 4 4
Skin Erosion 3 3
Physical Asymmetry 3 3
Discomfort 3 3
Pneumothorax 3 3
Injury 3 3
No Consequences Or Impact To Patient 3 3
Not Applicable 3 3
Foreign Body Reaction 3 3
Loss of Range of Motion 3 3
Spinal Cord Injury 2 2
Nervous System Injury 2 2
Foreign Body In Patient 2 2
Spinal Column Injury 2 2
Reaction 2 2
Pocket Erosion 2 2
Nerve Damage 2 2
Skin Irritation 2 2
Erosion 2 2
Seroma 2 2
Joint Disorder 2 2
Joint Laxity 2 2
Bacterial Infection 1 1
Unspecified Nervous System Problem 1 1
Hemorrhage/Bleeding 1 1
Osteolysis 1 1
Exsanguination 1 1
Hematoma 1 1
Respiratory Failure 1 1
Calcium Deposits/Calcification 1 1
Cerebrospinal Fluid Leakage 1 1
Decreased Sensitivity 1 1
Blood Loss 1 1
Vertebral Fracture 1 1
Weakness 1 1
Adhesion(s) 1 1
Pleural Effusion 1 1
Respiratory Distress 1 1
Adult Respiratory Distress Syndrome 1 1
Sepsis 1 1
Ulcer 1 1
Joint Dislocation 1 1
Ischemia 1 1
Respiratory Arrest 1 1
Convulsion/Seizure 1 1
Septic Shock 1 1

-
-