TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	456	456
Break	233	233
Fracture	77	77
Detachment of Device or Device Component	53	53
Mechanical Jam	38	38
Material Split, Cut or Torn	23	23
Material Twisted/Bent	20	20
Appropriate Term/Code Not Available	20	20
Material Deformation	20	20
Migration	19	19
Device-Device Incompatibility	18	18
Defective Device	18	18
Use of Device Problem	17	17
Entrapment of Device	14	14
Physical Resistance/Sticking	13	13
Insufficient Information	12	12
Device Dislodged or Dislocated	11	11
Activation Failure	10	10
Patient Device Interaction Problem	10	10
Material Fragmentation	9	9
Improper or Incorrect Procedure or Method	8	8
Failure to Power Up	8	8
Failure to Advance	8	8
Loose or Intermittent Connection	7	7
Unintended Movement	7	7
Migration or Expulsion of Device	6	6
Difficult to Remove	6	6
Device Slipped	5	5
Positioning Problem	5	5
Material Frayed	4	4
Unstable	4	4
Output Problem	4	4
Manufacturing, Packaging or Shipping Problem	4	4
Therapeutic or Diagnostic Output Failure	4	4
Material Rupture	3	3
Positioning Failure	3	3
Product Quality Problem	3	3
Material Separation	3	3
Loosening of Implant Not Related to Bone-Ingrowth	3	3
Tear, Rip or Hole in Device Packaging	3	3
Malposition of Device	3	3
Off-Label Use	3	3
Inadequacy of Device Shape and/or Size	2	2
Material Protrusion/Extrusion	2	2
Packaging Problem	2	2
No Apparent Adverse Event	2	2
Connection Problem	2	2
Electrical /Electronic Property Problem	2	2
Device Displays Incorrect Message	2	2
Delivered as Unsterile Product	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	235	235
Insufficient Information	174	174
Failure of Implant	101	101
Unspecified Infection	91	91
Implant Pain	64	64
No Consequences Or Impact To Patient	59	59
Non-union Bone Fracture	51	51
No Code Available	45	45
Swelling/ Edema	44	44
Pain	44	44
Injury	44	44
Post Operative Wound Infection	37	37
Foreign Body In Patient	35	35
No Known Impact Or Consequence To Patient	35	35
Not Applicable	25	25
Tissue Damage	24	24
Discomfort	22	22
Bone Fracture(s)	17	17
No Patient Involvement	15	15
Cellulitis	14	14
Device Embedded In Tissue or Plaque	13	13
Unspecified Tissue Injury	11	11
Inflammation	10	10
Loss of Range of Motion	10	10
Swelling	9	9
Impaired Healing	8	8
Physical Asymmetry	8	8
Deformity/ Disfigurement	6	6
Bacterial Infection	6	6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	6	6
Hypersensitivity/Allergic reaction	6	6
Skin Inflammation/ Irritation	6	6
Nerve Damage	6	6
Organ Dehiscence	5	5
Malunion of Bone	5	5
Osteolysis	5	5
Unspecified Musculoskeletal problem	5	5
No Information	5	5
Joint Disorder	5	5
Fall	4	4
Patient Problem/Medical Problem	4	4
Neuropathy	3	3
Arthritis	3	3
Fracture, Arm	3	3
Necrosis	3	3
Pulmonary Embolism	2	2
Edema	2	2
Erythema	2	2
Synovitis	2	2
Perforation	2	2