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
Detachment Of Device Component	4	4
Overheating of Device	4	4
Difficult to Remove	3	3
Mechanical Problem	3	3
Material Fragmentation	2	2
Component Falling	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
Material Integrity Problem	1	1
Naturally Worn	1	1
Positioning Problem	1	1
Temperature Problem	1	1
Insufficient Information	1	1
Excessive Heating	1	1
Separation Problem	1	1
Failure to Power Up	1	1
Failure To Service	1	1
Sticking	1	1
Vibration	1	1
Defective Device	1	1
Contamination /Decontamination Problem	1	1
Material Disintegration	1	1
Entrapment of Device	1	1
Nonstandard Device	1	1
No Device Output	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
Device Embedded In Tissue or Plaque	12	12
No Clinical Signs, Symptoms or Conditions	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
Injury	1	1
No Patient Involvement	1	1
Laceration(s)	1	1
Skin Discoloration	1	1
Failure of Implant	1	1
Blister	1	1