TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	12	12
Insufficient Information	9	9
Device Operates Differently Than Expected	7	7
Improper or Incorrect Procedure or Method	5	5
Patient-Device Incompatibility	4	4
Patient Device Interaction Problem	3	3
Sharp Edges	2	2
Biocompatibility	2	2
Use of Device Problem	2	2
Entrapment of Device	1	1
Separation Failure	1	1
Therapeutic or Diagnostic Output Failure	1	1
Detachment of Device or Device Component	1	1
Component Falling	1	1
Detachment Of Device Component	1	1
Solder Joint Fracture	1	1
Appropriate Term/Code Not Available	1	1
Device Dislodged or Dislocated	1	1
Difficult to Remove	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Tooth Fracture	16	16
Hypersensitivity/Allergic reaction	4	4
Tissue Damage	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
No Code Available	3	3
Abrasion	3	3
Injury	3	3
Pressure Sores	3	3
Unspecified Infection	2	2
Abdominal Pain	2	2
Sleep Dysfunction	2	2
Nausea	2	2
Dizziness	2	2
Foreign Body Reaction	2	2
Foreign Body In Patient	2	2
Depression	2	2
Shaking/Tremors	2	2
Ulcer	2	2
Blurred Vision	2	2
Headache	2	2
Hot Flashes/Flushes	2	2
Irritability	2	2
Syncope/Fainting	1	1
Speech Disorder	1	1
Arthralgia	1	1
Metal Related Pathology	1	1
Fatigue	1	1
Skin Inflammation/ Irritation	1	1
Inflammation	1	1
Cognitive Changes	1	1
Alteration In Body Temperature	1	1
No Known Impact Or Consequence To Patient	1	1
Erythema	1	1
Vomiting	1	1
Diarrhea	1	1
Visual Impairment	1	1
Ulceration	1	1
Swelling/ Edema	1	1
Loss of consciousness	1	1
Device Embedded In Tissue or Plaque	1	1