TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Device-Device Incompatibility	1179	1179
Break	456	456
Unintended Movement	273	273
Failure to Cut	238	238
Material Deformation	183	183
Naturally Worn	154	154
Scratched Material	132	132
Difficult to Advance	115	115
Adverse Event Without Identified Device or Use Problem	76	76
Structural Problem	75	75
Material Twisted/Bent	70	70
Fracture	45	45
Device Damaged Prior to Use	44	44
No Apparent Adverse Event	42	42
Material Integrity Problem	38	38
Dull, Blunt	33	33
Contamination /Decontamination Problem	31	31
Chemical Problem	29	29
Mechanical Jam	27	27
Illegible Information	25	25
Loose or Intermittent Connection	25	25
Physical Resistance/Sticking	24	24
Inadequacy of Device Shape and/or Size	24	24
Device Slipped	19	19
Missing Information	16	16
Difficult to Open or Close	16	16
Entrapment of Device	14	14
Detachment of Device or Device Component	11	11
Device Dislodged or Dislocated	10	10
Device Contaminated During Manufacture or Shipping	8	8
Tear, Rip or Hole in Device Packaging	7	7
Device Markings/Labelling Problem	6	6
Crack	5	5
Off-Label Use	4	4
Corroded	4	4
Defective Device	3	3
Difficult to Remove	3	3
Use of Device Problem	3	3
Device Damaged by Another Device	3	3
Manufacturing, Packaging or Shipping Problem	2	2
Positioning Problem	1	1
Output Problem	1	1
Difficult to Open or Remove Packaging Material	1	1
Backflow	1	1
Material Discolored	1	1
Component Missing	1	1
Mechanical Problem	1	1
Material Frayed	1	1
Appropriate Term/Code Not Available	1	1
Noise, Audible	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1806	1806
No Consequences Or Impact To Patient	338	338
Insufficient Information	312	312
No Code Available	137	137
Bone Fracture(s)	26	26
Limb Fracture	25	25
Not Applicable	19	19
No Known Impact Or Consequence To Patient	18	18
Unspecified Tissue Injury	16	16
Joint Dislocation	10	10
Pain	10	10
Unspecified Infection	7	7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	5	5
Joint Laxity	5	5
Foreign Body In Patient	3	3
No Patient Involvement	3	3
No Information	2	2
Loss of Range of Motion	2	2
Damage to Ligament(s)	1	1
Fatigue	1	1
Foreign Body Reaction	1	1
Thrombosis/Thrombus	1	1
Discomfort	1	1
Nerve Damage	1	1
Scar Tissue	1	1
Fall	1	1
Physical Asymmetry	1	1
Deformity/ Disfigurement	1	1
Low Blood Pressure/ Hypotension	1	1
Distress	1	1