TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	183	183
Fracture	77	77
Material Fragmentation	22	22
Entrapment of Device	17	17
Failure to Cut	16	16
Mechanical Jam	8	8
Material Separation	7	7
Device-Device Incompatibility	6	6
Residue After Decontamination	5	5
Device Markings/Labelling Problem	3	3
Insufficient Information	3	3
Contamination /Decontamination Problem	3	3
Delivered as Unsterile Product	3	3
Material Deformation	3	3
Physical Resistance/Sticking	2	2
Material Integrity Problem	2	2
Adverse Event Without Identified Device or Use Problem	2	2
Detachment of Device or Device Component	2	2
Firing Problem	2	2
Improper or Incorrect Procedure or Method	2	2
Dull, Blunt	2	2
Unstable	1	1
Material Split, Cut or Torn	1	1
Mechanical Problem	1	1
Crack	1	1
Material Discolored	1	1
Use of Device Problem	1	1
Component Missing	1	1
Misassembled	1	1
Inadequacy of Device Shape and/or Size	1	1
Tear, Rip or Hole in Device Packaging	1	1
Failure to Fire	1	1
No Apparent Adverse Event	1	1
Failure to Cycle	1	1
Difficult to Open or Close	1	1
Flaked	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	228	228
Foreign Body In Patient	29	29
Insufficient Information	29	29
No Consequences Or Impact To Patient	15	15
No Information	10	10
No Known Impact Or Consequence To Patient	9	9
Device Embedded In Tissue or Plaque	7	7
Injury	3	3
Not Applicable	2	2
Failure of Implant	1	1
Metal Related Pathology	1	1
Perforation	1	1
Cerebrospinal Fluid Leakage	1	1
Spinal Cord Injury	1	1