TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	4845	4845
Naturally Worn	1570	1570
Device-Device Incompatibility	1298	1298
Scratched Material	1046	1046
Crack	799	799
Detachment of Device or Device Component	676	676
Material Deformation	468	468
Material Twisted/Bent	402	402
Contamination /Decontamination Problem	312	312
Illegible Information	302	302
Fracture	292	292
Material Integrity Problem	206	206
Mechanical Jam	149	149
No Apparent Adverse Event	149	149
Material Discolored	141	141
Peeled/Delaminated	136	136
Adverse Event Without Identified Device or Use Problem	86	86
Component Missing	84	84
Unintended Movement	68	68
Entrapment of Device	66	66
Corroded	64	64
Use of Device Problem	53	53
Incorrect Measurement	48	48
Failure to Cut	40	40
Physical Resistance/Sticking	36	36
Appropriate Term/Code Not Available	26	26
Structural Problem	22	22
Dull, Blunt	18	18
Mechanical Problem	18	18
Insufficient Information	18	18
Device Dislodged or Dislocated	16	16
Loose or Intermittent Connection	15	15
Improper or Incorrect Procedure or Method	13	13
Compatibility Problem	12	12
Material Fragmentation	11	11
Loss of Osseointegration	10	10
Off-Label Use	9	9
Difficult to Remove	8	8
Difficult to Open or Close	8	8
Connection Problem	8	8
Loss of or Failure to Bond	6	6
Difficult or Delayed Separation	6	6
Inadequacy of Device Shape and/or Size	6	6
Device Slipped	5	5
Migration	5	5
Fitting Problem	4	4
Difficult to Insert	4	4
Positioning Problem	4	4
Manufacturing, Packaging or Shipping Problem	4	4
Separation Problem	4	4

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	7956	7956
No Consequences Or Impact To Patient	1264	1264
Insufficient Information	741	741
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	32	32
No Information	29	29
Pain	23	23
Bone Fracture(s)	17	17
Unspecified Infection	14	14
Limb Fracture	9	9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	8	8
Injury	6	6
Joint Dislocation	5	5
Physical Asymmetry	4	4
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
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
Death	1	1
Patient Problem/Medical Problem	1	1
Pulmonary Embolism	1	1
Ambulation Difficulties	1	1