TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Mechanical Problem	82	82
Unintended System Motion	81	81
Adverse Event Without Identified Device or Use Problem	75	75
Patient Device Interaction Problem	8	8
Break	5	5
Detachment of Device or Device Component	3	3
No Apparent Adverse Event	3	3
Insufficient Information	2	2
Material Twisted/Bent	2	2
Collapse	2	2
Fracture	2	2
Defective Device	2	2
Patient-Device Incompatibility	1	1
Contamination /Decontamination Problem	1	1
Loose or Intermittent Connection	1	1
Component Incompatible	1	1
Crack	1	1
Inadequacy of Device Shape and/or Size	1	1
Device Slipped	1	1
Unexpected Therapeutic Results	1	1
Unstable	1	1
Use of Device Problem	1	1
Defective Component	1	1
Failure to Align	1	1
Material Integrity Problem	1	1
Unintended Movement	1	1
Physical Resistance/Sticking	1	1
Device Fell	1	1
Misassembled During Installation	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	82	82
Damage to Ligament(s)	62	62
Injury	9	9
Fall	6	6
No Consequences Or Impact To Patient	4	4
Pain	3	3
Tissue Damage	3	3
Laceration(s)	3	3
Patient Problem/Medical Problem	3	3
No Known Impact Or Consequence To Patient	3	3
Insufficient Information	3	3
Joint Dislocation	2	2
Bone Fracture(s)	2	2
Hematoma	2	2
Swelling	2	2
Rash	1	1
Sprain	1	1
Convulsion, Clonic	1	1
Convulsion, Tonic	1	1
Hip Fracture	1	1
Hypersensitivity/Allergic reaction	1	1
Inflammation	1	1
Edema	1	1
Neuropathy	1	1
Skin Tears	1	1
Ambulation Difficulties	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Thrombosis/Thrombus	1	1
Limb Fracture	1	1
Blister	1	1
Unspecified Tissue Injury	1	1
Swelling/ Edema	1	1