TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	1046	1046
Material Deformation	156	156
Material Separation	152	152
Degraded	144	144
Material Twisted/Bent	129	129
Detachment of Device or Device Component	119	119
Difficult to Open or Close	114	114
Mechanical Jam	108	108
Device Contaminated During Manufacture or Shipping	64	64
Device-Device Incompatibility	48	48
Material Fragmentation	40	40
Dull, Blunt	39	39
Fracture	37	37
Adverse Event Without Identified Device or Use Problem	29	29
Corroded	24	24
Use of Device Problem	23	23
Flaked	22	22
Device Contamination with Chemical or Other Material	21	21
Appropriate Term/Code Not Available	20	20
Physical Resistance/Sticking	20	20
Device Damaged by Another Device	18	18
Defective Device	17	17
Crack	16	16
Failure to Cut	16	16
Component Missing	16	16
Mechanical Problem	15	15
Insufficient Information	14	14
Leak/Splash	11	11
Material Integrity Problem	11	11
Fluid/Blood Leak	10	10
Material Split, Cut or Torn	10	10
Device Markings/Labelling Problem	10	10
Device Dislodged or Dislocated	9	9
Failure to Advance	9	9
Loose or Intermittent Connection	8	8
Delivered as Unsterile Product	7	7
Sharp Edges	7	7
Difficult to Remove	7	7
Entrapment of Device	7	7
Contamination /Decontamination Problem	6	6
Scratched Material	6	6
Packaging Problem	6	6
Firing Problem	5	5
Connection Problem	5	5
Material Discolored	5	5
Failure to Align	5	5
Illegible Information	5	5
Device Damaged Prior to Use	5	5
Contamination	4	4
Failure to Cycle	4	4

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1568	1568
No Known Impact Or Consequence To Patient	226	226
No Consequences Or Impact To Patient	218	218
Insufficient Information	135	135
Foreign Body In Patient	127	127
No Information	47	47
Not Applicable	32	32
No Patient Involvement	32	32
Device Embedded In Tissue or Plaque	30	30
No Code Available	17	17
Pain	14	14
Injury	13	13
Tissue Damage	10	10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	6	6
Failure of Implant	5	5
Laceration(s)	5	5
Unspecified Tissue Injury	4	4
Perforation	3	3
Rupture	3	3
Extravasation	3	3
Swelling/ Edema	3	3
Hypersensitivity/Allergic reaction	2	2
Scar Tissue	2	2
Neuropathy	1	1
Patient Problem/Medical Problem	1	1
Inadequate Osseointegration	1	1
Unspecified Musculoskeletal problem	1	1
Itching Sensation	1	1
Post Operative Wound Infection	1	1
Paresthesia	1	1
Burning Sensation	1	1
Needle Stick/Puncture	1	1
Exposure to Body Fluids	1	1
Nerve Damage	1	1
Loss of Range of Motion	1	1
Numbness	1	1
Capsular Contracture	1	1