TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Failure to Seal	15	15
Difficult to Open or Close	13	13
Mechanical Problem	13	13
Device Operates Differently Than Expected	10	10
Improper or Incorrect Procedure or Method	6	6
Material Integrity Problem	5	5
Insufficient Information	4	4
Loosening of Implant Not Related to Bone-Ingrowth	4	4
Material Twisted/Bent	4	4
Patient Device Interaction Problem	3	3
Material Deformation	3	3
Activation, Positioning or Separation Problem	2	2
Defective Device	2	2
Positioning Problem	2	2
Defective Component	2	2
Device Dislodged or Dislocated	2	2
Fracture	2	2
Adverse Event Without Identified Device or Use Problem	2	2
Device Handling Problem	2	2
Component Falling	2	2
Migration or Expulsion of Device	2	2
Break	2	2
Failure to Align	2	2
Loose or Intermittent Connection	2	2
Device Slipped	1	1
Component or Accessory Incompatibility	1	1
Device Markings/Labelling Problem	1	1
Difficult to Fold, Unfold or Collapse	1	1
Wrong Label	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Failure to Form Staple	1	1
Firing Problem	1	1
Inadequate Instructions for Healthcare Professional	1	1
Detachment Of Device Component	1	1
Activation Problem	1	1
Use of Device Problem	1	1
Device Difficult to Setup or Prepare	1	1
Migration	1	1
Product Quality Problem	1	1
Normal	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	33	33
No Clinical Signs, Symptoms or Conditions	22	22
No Consequences Or Impact To Patient	11	11
Insufficient Information	8	8
Aneurysm	8	8
No Information	5	5
No Code Available	3	3
Patient Problem/Medical Problem	2	2
Failure of Implant	2	2
Intracranial Hemorrhage	2	2
No Patient Involvement	2	2
High Blood Pressure/ Hypertension	1	1
Death	1	1
Stroke/CVA	1	1
Brain Injury	1	1
Test Result	1	1
Peripheral Vascular Disease	1	1
Anemia	1	1
Foreign Body Reaction	1	1
Foreign Body In Patient	1	1
Swelling	1	1
Ruptured Aneurysm	1	1
Loss of consciousness	1	1
Hemorrhage/Bleeding	1	1