TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	6794	6818
Device-Device Incompatibility	1857	1859
Naturally Worn	1640	1643
Scratched Material	1320	1320
Crack	1063	1065
Detachment of Device or Device Component	1043	1047
Material Deformation	819	822
Illegible Information	475	475
Contamination /Decontamination Problem	364	364
Fracture	350	354
Material Twisted/Bent	337	338
No Apparent Adverse Event	291	291
Material Integrity Problem	247	247
Mechanical Jam	177	177
Peeled/Delaminated	154	157
Material Discolored	145	145
Unintended Movement	93	93
Adverse Event Without Identified Device or Use Problem	93	96
Entrapment of Device	83	85
Corroded	67	67
Incorrect Measurement	53	53
Use of Device Problem	51	51
Failure to Cut	50	50
Component Missing	47	47
Structural Problem	29	30
Improper or Incorrect Procedure or Method	24	24
Material Fragmentation	17	17
Mechanical Problem	16	16
Physical Resistance/Sticking	16	16
Insufficient Device Problem Information	16	16
Compatibility Problem	14	14
Off-Label Use	12	12
Difficult to Remove	10	10
Appropriate Device Problem Term/Code Not Available	10	11
Loss of Osseointegration	9	9
Dull, Blunt	9	9
Difficult to Open or Close	9	9
Device Dislodged or Dislocated	8	8
Loose or Intermittent Connection	7	7
Loss of or Failure to Bond	6	6
Difficult or Delayed Separation	5	5
Residue After Decontamination	5	5
Manufacturing, Packaging or Shipping Problem	4	4
Device Slipped	4	4
Inadequacy of Device Shape and/or Size	4	5
Difficult to Advance	4	4
Inaccurate Information	4	4
Migration	4	5
Defective Device	4	4
Difficult to Insert	4	4

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	11762	11794
Insufficient Information	1221	1226
No Consequences Or Impact To Patient	660	660
No Code Available	120	120
No Patient Involvement	66	66
Foreign Body In Patient	53	53
No Known Impact Or Consequence To Patient	42	42
Pain	23	23
Bone Fracture(s)	22	24
Not Applicable	17	17
Unspecified Infection	14	14
No Information	11	11
Limb Fracture	10	11
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	9	9
Physical Asymmetry	6	6
Loss of Range of Motion	4	4
Joint Laxity	4	4
Failure of Implant	4	4
Injury	3	3
Unspecified Tissue Injury	3	3
Metal Related Pathology	3	3
Cyst(s)	3	3
Bone Notching	2	2
Laceration(s)	2	4
Discomfort	2	2
Joint Dislocation	2	2
Swelling/ Edema	2	2
Osteolysis	2	2
Bruise/Contusion	2	2
Inflammation	1	1
Ambulation or Postural Difficulties	1	1
Adhesion(s)	1	1
Nonunion/Delayed-union Bone Fracture	1	1
Spinal Cord Injury	1	1
Depression	1	1
Unspecified Musculoskeletal problem	1	1
Unspecified Nervous System Problem	1	1
Pulmonary Embolism	1	1
Device Embedded In Tissue or Plaque	1	1
Bacterial Infection	1	1
Unequal Limb Length	1	1
Nerve Damage	1	1
Synovitis	1	1