TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Fracture	32	32
Break	9	9
Adverse Event Without Identified Device or Use Problem	8	8
Insufficient Information	4	4
Patient-Device Incompatibility	4	4
Detachment of Device or Device Component	2	2
Incorrect Device Or Component Shipped	2	2
Poor Quality Image	2	2
Difficult To Position	1	1
Product Quality Problem	1	1
Material Too Rigid or Stiff	1	1
Inadequacy of Device Shape and/or Size	1	1
Use of Device Problem	1	1
Improper or Incorrect Procedure or Method	1	1
Component Missing	1	1
Structural Problem	1	1
Defective Device	1	1
Material Deformation	1	1
Material Integrity Problem	1	1
Device Operates Differently Than Expected	1	1
Detachment Of Device Component	1	1
Component Incompatible	1	1
Mechanical Problem	1	1
Patient Device Interaction Problem	1	1
Positioning Problem	1	1
Pressure Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Consequences Or Impact To Patient	23	23
No Known Impact Or Consequence To Patient	22	22
Pressure Sores	8	8
No Clinical Signs, Symptoms or Conditions	4	4
Injury	3	3
No Information	3	3
No Code Available	3	3
Tissue Breakdown	2	2
Swelling/ Edema	2	2
Ulcer	2	2
Pain	2	2
Skin Irritation	2	2
Swelling	1	1
Tissue Damage	1	1
Loss of Range of Motion	1	1
Urticaria	1	1
Brain Injury	1	1
Pulmonary Embolism	1	1
Abrasion	1	1
Erythema	1	1
Fall	1	1
Bone Fracture(s)	1	1
Head Injury	1	1
Unspecified Infection	1	1
Inflammation	1	1
Irritation	1	1
Itching Sensation	1	1
Insufficient Information	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Respiratory Arrest	1	1
Spinal Cord Injury	1	1
Neck Pain	1	1
Low Oxygen Saturation	1	1
Confusion/ Disorientation	1	1
Blood Loss	1	1