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	12	12
Difficult to Open or Close	10	10
Device Operates Differently Than Expected	9	9
Improper or Incorrect Procedure or Method	6	6
Material Integrity Problem	5	5
Loosening of Implant Not Related to Bone-Ingrowth	4	4
Material Twisted/Bent	4	4
Migration or Expulsion of Device	3	3
Insufficient Information	3	3
Patient Device Interaction Problem	3	3
Activation, Positioning or Separation Problem	2	2
Break	2	2
Defective Component	2	2
Defective Device	2	2
Positioning Problem	2	2
Failure to Align	2	2
Adverse Event Without Identified Device or Use Problem	2	2
Device Handling Problem	2	2
Fracture	2	2
Loose or Intermittent Connection	2	2
Component or Accessory Incompatibility	1	1
Activation Problem	1	1
Difficult to Fold, Unfold or Collapse	1	1
Wrong Label	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Device Difficult to Setup or Prepare	1	1
Use of Device Problem	1	1
Material Deformation	1	1
Normal	1	1
Product Quality Problem	1	1
Migration	1	1
Device Dislodged or Dislocated	1	1
Failure to Form Staple	1	1
Firing Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	29	29
No Clinical Signs, Symptoms or Conditions	22	22
No Consequences Or Impact To Patient	10	10
Insufficient Information	8	8
Aneurysm	8	8
Patient Problem/Medical Problem	2	2
Failure of Implant	2	2
No Code Available	2	2
Intracranial Hemorrhage	2	2
High Blood Pressure/ Hypertension	1	1
Stroke/CVA	1	1
Death	1	1
Brain Injury	1	1
Peripheral Vascular Disease	1	1
Foreign Body Reaction	1	1
Foreign Body In Patient	1	1
Swelling	1	1
No Patient Involvement	1	1
Ruptured Aneurysm	1	1
Hemorrhage/Bleeding	1	1
Loss of consciousness	1	1