TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	308	308
Separation Failure	8	8
Peeled/Delaminated	5	5
Flaked	5	5
Material Integrity Problem	5	5
Bent	4	4
Adverse Event Without Identified Device or Use Problem	3	3
Detachment of Device or Device Component	2	2
Device Operates Differently Than Expected	2	2
Component Incompatible	2	2
Crack	1	1
Patient-Device Incompatibility	1	1
Material Twisted/Bent	1	1
Labelling, Instructions for Use or Training Problem	1	1
Material Separation	1	1
Tear, Rip or Hole in Device Packaging	1	1
Fracture	1	1
Failure to Osseointegrate	1	1
Problem with Sterilization	1	1
Device Damaged by Another Device	1	1
Mechanical Jam	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Unraveled Material	1	1
Material Fragmentation	1	1
Detachment Of Device Component	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Consequences Or Impact To Patient	151	151
No Clinical Signs, Symptoms or Conditions	114	114
No Known Impact Or Consequence To Patient	54	54
Insufficient Information	30	30
No Information	11	11
No Patient Involvement	7	7
Foreign Body In Patient	3	3
Device Embedded In Tissue or Plaque	3	3
Tooth Fracture	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Hypersensitivity/Allergic reaction	1	1
No Code Available	1	1
Failure of Implant	1	1
Bone Fracture(s)	1	1
Injury	1	1
Needle Stick/Puncture	1	1
Erythema	1	1
Pain	1	1
Laceration(s)	1	1
Tissue Damage	1	1