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 Code	MDI
Regulation Number	888.3070
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	86	86
Patient Device Interaction Problem	45	45
Material Integrity Problem	18	18
Mechanical Problem	7	7
Break	2	2
Device Slipped	1	1
Activation, Positioning or Separation Problem	1	1
Compatibility Problem	1	1
Insufficient Information	1	1
Material Separation	1	1
Fracture	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	37	37
Insufficient Information	24	24
Failure of Implant	21	21
Post Operative Wound Infection	19	19
Unspecified Tissue Injury	18	18
No Clinical Signs, Symptoms or Conditions	17	17
Unspecified Infection	16	16
Impaired Healing	10	10
Non-union Bone Fracture	8	8
Pain	8	8
Wound Dehiscence	6	6
Skin Inflammation/ Irritation	4	4
Physical Asymmetry	4	4
Paralysis	4	4
Pneumothorax	3	3
Unspecified Nervous System Problem	3	3
Pneumonia	3	3
Nervous System Injury	2	2
Bone Fracture(s)	2	2
Hematoma	2	2
Skin Erosion	2	2
Joint Laxity	2	2
Vertebral Fracture	1	1
Respiratory Failure	1	1
Spinal Cord Injury	1	1
Pocket Erosion	1	1
Hemorrhage/Bleeding	1	1
Bacterial Infection	1	1
Convulsion/Seizure	1	1
Cerebrospinal Fluid Leakage	1	1
Abscess	1	1
Osteolysis	1	1
Septic Shock	1	1
Loss of Range of Motion	1	1
Pleural Effusion	1	1
Nerve Damage	1	1
Seroma	1	1
Ischemia	1	1
Inflammation	1	1
Exsanguination	1	1
Adhesion(s)	1	1
Metal Related Pathology	1	1
Respiratory Arrest	1	1
Adult Respiratory Distress Syndrome	1	1
Decreased Sensitivity	1	1