TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	7645	7645
Crack	1047	1047
Naturally Worn	894	894
Device-Device Incompatibility	675	675
Fracture	604	604
Material Twisted/Bent	333	333
Scratched Material	194	194
Contamination /Decontamination Problem	191	191
Material Deformation	185	185
Material Integrity Problem	124	124
No Apparent Adverse Event	106	106
Mechanical Jam	74	74
Adverse Event Without Identified Device or Use Problem	67	67
Unintended Movement	60	60
Detachment of Device or Device Component	59	59
Entrapment of Device	38	38
Illegible Information	33	33
Component Missing	31	31
Physical Resistance/Sticking	23	23
Material Discolored	20	20
Failure to Disconnect	19	19
Mechanical Problem	17	17
Loose or Intermittent Connection	16	16
Device Slipped	12	12
Appropriate Term/Code Not Available	12	12
Material Fragmentation	12	12
Manufacturing, Packaging or Shipping Problem	11	11
Device Contamination with Chemical or Other Material	11	11
Difficult to Remove	10	10
Corroded	9	9
Structural Problem	8	8
Use of Device Problem	8	8
Compatibility Problem	6	6
Insufficient Information	6	6
Connection Problem	6	6
Off-Label Use	6	6
Deformation Due to Compressive Stress	5	5
Defective Device	5	5
Device Dislodged or Dislocated	4	4
Improper or Incorrect Procedure or Method	4	4
Fitting Problem	4	4
Dull, Blunt	3	3
Material Separation	3	3
Positioning Problem	3	3
Failure to Clean Adequately	2	2
Degraded	2	2
Failure to Cut	2	2
Mechanics Altered	2	2
Device Damaged by Another Device	2	2
Problem with Sterilization	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	7241	7241
No Consequences Or Impact To Patient	2552	2552
Insufficient Information	641	641
No Code Available	183	183
No Known Impact Or Consequence To Patient	125	125
No Patient Involvement	64	64
Not Applicable	62	62
Foreign Body In Patient	39	39
No Information	13	13
Device Embedded In Tissue or Plaque	6	6
Unspecified Infection	5	5
Pain	5	5
Failure of Implant	4	4
Injury	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Bone Fracture(s)	2	2
Patient Problem/Medical Problem	1	1
Inadequate Osseointegration	1	1
Unspecified Musculoskeletal problem	1	1
Hematoma	1	1
Osteopenia/ Osteoporosis	1	1
Needle Stick/Puncture	1	1
Thrombosis	1	1
Reaction	1	1
Non-union Bone Fracture	1	1