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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
DEPUY SYNTHES SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 1
ORTHOPEDIATRICS CORP.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 109 109
2015 174 174
2016 31 31
2017 64 64
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 346 346
Break 92 92
Migration or Expulsion of Device 82 82
Migration 38 38
Patient Device Interaction Problem 33 33
Device Dislodged or Dislocated 20 20
Material Integrity Problem 15 15
Unintended Movement 13 13
Fracture 7 7
Loose or Intermittent Connection 5 5
Mechanical Problem 5 5
Device Slipped 5 5
Device Operates Differently Than Expected 5 5
Appropriate Term/Code Not Available 4 4
No Apparent Adverse Event 4 4
Material Twisted/Bent 3 3
Failure to Osseointegrate 3 3
Material Fragmentation 3 3
Difficult to Remove 3 3
Material Separation 3 3
Sticking 2 2
Component Missing 2 2
Insufficient Information 2 2
Detachment of Device or Device Component 2 2
Failure To Adhere Or Bond 1 1
Compatibility Problem 1 1
Mechanical Jam 1 1
Activation Failure 1 1
Noise, Audible 1 1
Device Issue 1 1
Loss of Osseointegration 1 1
Failure to Disconnect 1 1
Malposition of Device 1 1
Activation, Positioning or Separation Problem 1 1
Device Inoperable 1 1
Fitting Problem 1 1
Inadequacy of Device Shape and/or Size 1 1
Nonstandard Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 235 235
Failure of Implant 145 145
Unspecified Infection 128 128
No Known Impact Or Consequence To Patient 66 66
Pain 41 41
Impaired Healing 40 40
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 36 36
Post Operative Wound Infection 26 26
Bone Fracture(s) 26 26
Nerve Damage 18 18
Tissue Damage 17 17
Wound Dehiscence 16 16
No Clinical Signs, Symptoms or Conditions 16 16
Unspecified Tissue Injury 16 16
Neurological Deficit/Dysfunction 13 13
Reaction 12 12
Non-union Bone Fracture 8 8
Ossification 8 8
Paralysis 7 7
Pneumonia 7 7
Pneumothorax 6 6
Erosion 5 5
Joint Swelling 5 5
Skin Erosion 5 5
No Consequences Or Impact To Patient 4 4
Sedation 4 4
Fever 4 4
Pulmonary Insufficiency 4 4
Respiratory Distress 4 4
Skin Inflammation/ Irritation 4 4
Insufficient Information 4 4
Physical Asymmetry 3 3
Spinal Cord Injury 3 3
Loss of Range of Motion 3 3
Foreign Body Reaction 3 3
Seroma 3 3
Device Embedded In Tissue or Plaque 3 3
Not Applicable 3 3
Discomfort 3 3
Injury 3 3
Joint Disorder 2 2
Weakness 2 2
Skin Irritation 2 2
Spinal Column Injury 2 2
Foreign Body In Patient 2 2
Nervous System Injury 2 2
Adult Respiratory Distress Syndrome 2 2
Bacterial Infection 2 2
Pocket Erosion 2 2
Joint Laxity 2 2
Convulsion/Seizure 1 1
Unspecified Nervous System Problem 1 1
Respiratory Arrest 1 1
Vertebral Fracture 1 1
Pulmonary Dysfunction 1 1
Sepsis 1 1
Septic Shock 1 1
Paresis 1 1
Pleural Effusion 1 1
Neuropathy 1 1
Undesired Nerve Stimulation 1 1
Adhesion(s) 1 1
Calcium Deposits/Calcification 1 1
Cerebrospinal Fluid Leakage 1 1
Dysphagia/ Odynophagia 1 1
Exsanguination 1 1
Fall 1 1
Hematoma 1 1
Hemorrhage/Bleeding 1 1
Irritation 1 1
Ischemia 1 1
Muscle Weakness 1 1
Muscular Rigidity 1 1
Respiratory Tract Infection 1 1
No Information 1 1
Perforation of Esophagus 1 1
Respiratory Failure 1 1
Loss Of Pulse 1 1
Vascular System (Circulation), Impaired 1 1
Blood Loss 1 1
Tissue Breakdown 1 1
Decreased Sensitivity 1 1
Toxic Shock Syndrome 1 1
Urinary Tract Infection 1 1
Tingling 1 1
Ulcer 1 1
Joint Dislocation 1 1
Osteolysis 1 1
Peroneal Nerve Palsy 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Synthes (USA) Products LLC II Aug-31-2015
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