TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Device-Device Incompatibility	1299	1299
Break	508	508
Unintended Movement	295	295
Failure to Cut	238	238
Material Deformation	197	197
Scratched Material	187	187
Naturally Worn	160	160
Difficult to Advance	115	115
Material Twisted/Bent	100	100
Adverse Event Without Identified Device or Use Problem	84	84
Structural Problem	67	67
Loose or Intermittent Connection	61	61
Fracture	60	60
Dull, Blunt	50	50
Device Damaged Prior to Use	44	44
Material Integrity Problem	36	36
Physical Resistance/Sticking	36	36
Mechanical Jam	34	34
Contamination /Decontamination Problem	33	33
Device Slipped	29	29
Chemical Problem	28	28
No Apparent Adverse Event	27	27
Inadequacy of Device Shape and/or Size	27	27
Connection Problem	24	24
Illegible Information	24	24
Difficult to Open or Close	17	17
Entrapment of Device	16	16
Appropriate Term/Code Not Available	15	15
Fitting Problem	13	13
Component Missing	11	11
Detachment of Device or Device Component	11	11
Crack	11	11
Device Dislodged or Dislocated	9	9
Difficult to Remove	8	8
Tear, Rip or Hole in Device Packaging	7	7
Device Contaminated During Manufacture or Shipping	7	7
Positioning Problem	6	6
Device Markings/Labelling Problem	6	6
Defective Device	4	4
Off-Label Use	4	4
Corroded	4	4
Device Contamination with Chemical or Other Material	4	4
Use of Device Problem	3	3
Difficult to Insert	3	3
Device Damaged by Another Device	3	3
Failure to Advance	2	2
Manufacturing, Packaging or Shipping Problem	2	2
Insufficient Information	2	2
Incomplete or Inadequate Connection	2	2
Failure to Clean Adequately	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1701	1701
No Consequences Or Impact To Patient	731	731
Insufficient Information	269	269
No Code Available	143	143
Not Applicable	57	57
Bone Fracture(s)	35	35
No Known Impact Or Consequence To Patient	27	27
Limb Fracture	23	23
Unspecified Tissue Injury	14	14
Pain	11	11
Joint Dislocation	9	9
No Information	9	9
Unspecified Infection	8	8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	5	5
Joint Laxity	5	5
No Patient Involvement	4	4
Foreign Body In Patient	3	3
Loss of Range of Motion	2	2
Damage to Ligament(s)	1	1
Fatigue	1	1
Inadequate Osseointegration	1	1
Foreign Body Reaction	1	1
Thrombosis/Thrombus	1	1
Nerve Damage	1	1
Discomfort	1	1
Fall	1	1
Scar Tissue	1	1
Physical Asymmetry	1	1
Deformity/ Disfigurement	1	1
Low Blood Pressure/ Hypotension	1	1
Distress	1	1