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
Mechanical Problem	13	13
Difficult to Open or Close	13	13
Device Operates Differently Than Expected	10	10
Improper or Incorrect Procedure or Method	6	6
Material Integrity Problem	5	5
Material Twisted/Bent	4	4
Insufficient Information	4	4
Loosening of Implant Not Related to Bone-Ingrowth	4	4
Material Deformation	3	3
Patient Device Interaction Problem	3	3
Device Handling Problem	2	2
Adverse Event Without Identified Device or Use Problem	2	2
Positioning Problem	2	2
Loose or Intermittent Connection	2	2
Activation, Positioning or Separation Problem	2	2
Defective Component	2	2
Failure to Align	2	2
Fracture	2	2
Defective Device	2	2
Migration or Expulsion of Device	2	2
Break	2	2
Component Falling	2	2
Difficult to Fold, Unfold or Collapse	1	1
Detachment Of Device Component	1	1
Normal	1	1
Device Difficult to Setup or Prepare	1	1
Product Quality Problem	1	1
Device Slipped	1	1
Use of Device Problem	1	1
Component or Accessory Incompatibility	1	1
Inadequate Instructions for Healthcare Professional	1	1
Failure to Form Staple	1	1
Device Markings/Labelling Problem	1	1
Device Dislodged or Dislocated	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Migration	1	1
Firing Problem	1	1
Activation Problem	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	20	20
No Consequences Or Impact To Patient	11	11
Aneurysm	8	8
Insufficient Information	8	8
No Information	5	5
No Code Available	3	3
Intracranial Hemorrhage	2	2
Failure of Implant	2	2
No Patient Involvement	2	2
Patient Problem/Medical Problem	2	2
Anemia	1	1
Test Result	1	1
Foreign Body In Patient	1	1
Brain Injury	1	1
Loss of consciousness	1	1
Peripheral Vascular Disease	1	1
Swelling	1	1
High Blood Pressure/ Hypertension	1	1
Stroke/CVA	1	1
Death	1	1
Foreign Body Reaction	1	1
Hemorrhage/Bleeding	1	1
Ruptured Aneurysm	1	1