TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	55	55
Material Separation	24	24
Fracture	12	12
Overheating of Device	4	4
Detachment Of Device Component	4	4
Mechanical Problem	3	3
Difficult to Remove	3	3
Material Fragmentation	2	2
Material Too Rigid or Stiff	2	2
Adverse Event Without Identified Device or Use Problem	2	2
Detachment of Device or Device Component	2	2
Component Falling	2	2
Separation Problem	1	1
Entrapment of Device	1	1
Insufficient Information	1	1
Material Disintegration	1	1
Positioning Problem	1	1
Material Integrity Problem	1	1
Defective Device	1	1
Vibration	1	1
Contamination /Decontamination Problem	1	1
Failure to Power Up	1	1
Sticking	1	1
Excessive Heating	1	1
Nonstandard Device	1	1
Naturally Worn	1	1
Failure To Service	1	1
No Device Output	1	1
Temperature Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Consequences Or Impact To Patient	41	41
No Known Impact Or Consequence To Patient	18	18
No Information	14	14
No Clinical Signs, Symptoms or Conditions	12	12
Device Embedded In Tissue or Plaque	12	12
Foreign Body In Patient	5	5
Burn(s)	4	4
Insufficient Information	4	4
No Code Available	3	3
Partial thickness (Second Degree) Burn	3	3
Unspecified Infection	2	2
Swelling	2	2
Failure of Implant	1	1
Blister	1	1
Skin Discoloration	1	1
Injury	1	1
No Patient Involvement	1	1
Laceration(s)	1	1