TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	5466	5466
Naturally Worn	1655	1655
Device-Device Incompatibility	1489	1489
Scratched Material	1136	1136
Crack	857	857
Detachment of Device or Device Component	744	744
Material Deformation	598	598
Material Twisted/Bent	404	404
Illegible Information	392	392
Fracture	328	328
Contamination /Decontamination Problem	327	327
Material Integrity Problem	214	214
No Apparent Adverse Event	188	188
Mechanical Jam	165	165
Material Discolored	156	156
Peeled/Delaminated	142	142
Adverse Event Without Identified Device or Use Problem	94	94
Component Missing	84	84
Entrapment of Device	76	76
Unintended Movement	74	74
Corroded	65	65
Use of Device Problem	53	53
Incorrect Measurement	52	52
Failure to Cut	43	43
Physical Resistance/Sticking	36	36
Appropriate Term/Code Not Available	25	25
Structural Problem	22	22
Improper or Incorrect Procedure or Method	21	21
Insufficient Information	20	20
Mechanical Problem	20	20
Dull, Blunt	18	18
Device Dislodged or Dislocated	16	16
Loose or Intermittent Connection	15	15
Material Fragmentation	15	15
Compatibility Problem	12	12
Off-Label Use	11	11
Loss of Osseointegration	11	11
Connection Problem	8	8
Difficult to Open or Close	8	8
Difficult to Remove	8	8
Loss of or Failure to Bond	7	7
Inadequacy of Device Shape and/or Size	6	6
Difficult or Delayed Separation	6	6
Migration	5	5
Residue After Decontamination	5	5
Device Slipped	5	5
Difficult to Insert	4	4
Positioning Problem	4	4
Manufacturing, Packaging or Shipping Problem	4	4
Device Damaged Prior to Use	4	4

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	8762	8762
No Consequences Or Impact To Patient	1264	1264
Insufficient Information	1089	1089
No Code Available	125	125
No Patient Involvement	95	95
Not Applicable	65	65
No Known Impact Or Consequence To Patient	64	64
Foreign Body In Patient	44	44
No Information	29	29
Pain	23	23
Bone Fracture(s)	20	20
Unspecified Infection	15	15
Limb Fracture	10	10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	8	8
Physical Asymmetry	6	6
Injury	6	6
Joint Dislocation	5	5
Joint Laxity	4	4
Loss of Range of Motion	4	4
Metal Related Pathology	3	3
Cyst(s)	3	3
Unspecified Tissue Injury	3	3
Device Embedded In Tissue or Plaque	2	2
Bruise/Contusion	2	2
Swelling/ Edema	2	2
Laceration(s)	2	2
Osteolysis	2	2
Failure of Implant	2	2
Nerve Damage	1	1
Discomfort	1	1
Depression	1	1
Unspecified Nervous System Problem	1	1
Foreign Body Reaction	1	1
Fall	1	1
Synovitis	1	1
Inflammation	1	1
Adhesion(s)	1	1
Unspecified Musculoskeletal problem	1	1
Non-union Bone Fracture	1	1
Inadequate Osseointegration	1	1
Infiltration into Tissue	1	1
Spinal Cord Injury	1	1
Death	1	1
Patient Problem/Medical Problem	1	1
Pulmonary Embolism	1	1
Ambulation Difficulties	1	1