TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	7038	7038
Naturally Worn	899	899
Crack	886	886
Device-Device Incompatibility	653	653
Fracture	521	521
Material Twisted/Bent	279	279
Contamination /Decontamination Problem	190	190
Material Deformation	188	188
Scratched Material	146	146
Material Integrity Problem	128	128
No Apparent Adverse Event	115	115
Mechanical Jam	73	73
Adverse Event Without Identified Device or Use Problem	60	60
Unintended Movement	60	60
Detachment of Device or Device Component	53	53
Illegible Information	36	36
Entrapment of Device	32	32
Failure to Disconnect	19	19
Mechanical Problem	17	17
Material Discolored	17	17
Manufacturing, Packaging or Shipping Problem	16	16
Component Missing	15	15
Device Slipped	11	11
Loose or Intermittent Connection	11	11
Material Fragmentation	10	10
Physical Resistance/Sticking	9	9
Difficult to Remove	9	9
Structural Problem	8	8
Off-Label Use	7	7
Corroded	6	6
Use of Device Problem	6	6
Improper or Incorrect Procedure or Method	6	6
Appropriate Term/Code Not Available	6	6
Compatibility Problem	6	6
Deformation Due to Compressive Stress	5	5
Insufficient Information	4	4
Solder Joint Fracture	4	4
Nonstandard Device	3	3
Device Dislodged or Dislocated	3	3
Material Separation	3	3
Flaked	2	2
Connection Problem	2	2
Failure to Cut	2	2
Device Damaged by Another Device	2	2
Mechanics Altered	2	2
Osseointegration Problem	2	2
Dull, Blunt	2	2
Fitting Problem	2	2
Noise, Audible	1	1
Residue After Decontamination	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	7699	7699
No Consequences Or Impact To Patient	1169	1169
Insufficient Information	916	916
No Code Available	162	162
No Known Impact Or Consequence To Patient	67	67
No Patient Involvement	40	40
Foreign Body In Patient	29	29
Not Applicable	21	21
Unspecified Infection	5	5
Pain	4	4
Failure of Implant	3	3
Device Embedded In Tissue or Plaque	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
No Information	2	2
Bone Fracture(s)	2	2
Inadequate Osseointegration	1	1
Unspecified Musculoskeletal problem	1	1
Hematoma	1	1
Osteopenia/ Osteoporosis	1	1
Needle Stick/Puncture	1	1
Unspecified Tissue Injury	1	1