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	6	6
Improper or Incorrect Procedure or Method	4	4
Material Integrity Problem	4	4
Loosening of Implant Not Related to Bone-Ingrowth	4	4
Patient Device Interaction Problem	3	3
Difficult to Open or Close	3	3
Break	2	2
Material Twisted/Bent	2	2
Positioning Problem	2	2
Defective Component	2	2
Migration or Expulsion of Device	2	2
Device Difficult to Setup or Prepare	1	1
Product Quality Problem	1	1
Failure to Align	1	1
Failure to Form Staple	1	1
Component or Accessory Incompatibility	1	1
Insufficient Information	1	1
Difficult to Fold, Unfold or Collapse	1	1
Fracture	1	1
Material Deformation	1	1
Firing Problem	1	1
Activation Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	20	20
Insufficient Information	8	8
No Consequences Or Impact To Patient	8	8
No Known Impact Or Consequence To Patient	5	5
Aneurysm	5	5
Failure of Implant	2	2
Patient Problem/Medical Problem	2	2
Swelling	1	1
Foreign Body Reaction	1	1
Hemorrhage/Bleeding	1	1
No Code Available	1	1
Ruptured Aneurysm	1	1
Brain Injury	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Peter Lazic Gmbh	II	Mar-12-2024