TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Misassembly by Users	16	16
Break	12	12
No Apparent Adverse Event	12	12
Use of Device Problem	9	10
Adverse Event Without Identified Device or Use Problem	7	7
Appropriate Term/Code Not Available	7	8
Unintended Movement	6	6
Insufficient Information	6	6
Mechanical Problem	5	5
Detachment of Device or Device Component	4	4
Fracture	4	4
Collapse	3	3
Device Fell	3	3
Material Twisted/Bent	3	3
Device Slipped	2	2
Defective Component	2	2
Defective Device	2	2
Misassembled During Installation	2	2
Mechanics Altered	2	2
Improper or Incorrect Procedure or Method	2	2
Unstable	1	1
Device Tipped Over	1	1
Material Erosion	1	1
Fail-Safe Did Not Operate	1	1
Patient Device Interaction Problem	1	1
Material Fragmentation	1	1
Sharp Edges	1	3
Misassembly During Maintenance/Repair	1	1
Material Deformation	1	1
Device Dislodged or Dislocated	1	1
Unintended System Motion	1	1
Connection Problem	1	1
Human-Device Interface Problem	1	1
Naturally Worn	1	1
Loss of or Failure to Bond	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	67	69
Fall	32	32
Head Injury	11	11
Bruise/Contusion	9	9
Bone Fracture(s)	8	8
Laceration(s)	6	6
Insufficient Information	5	6
Pain	2	2
Unspecified Tissue Injury	2	2
Unspecified Infection	1	1
Joint Dislocation	1	1
Brain Injury	1	1
Abrasion	1	1
Rash	1	1
Concussion	1	1
Eye Injury	1	1
Hydrocephalus	1	1
Limb Fracture	1	1
Swelling/ Edema	1	1
Hemorrhage/Bleeding	1	1