TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	2226	2676
Material Separation	118	118
Difficult to Remove	93	93
Entrapment of Device	60	60
Detachment of Device or Device Component	38	38
Detachment Of Device Component	9	9
Fracture	7	7
Material Fragmentation	7	7
Material Integrity Problem	5	231
Adverse Event Without Identified Device or Use Problem	5	5
Component Falling	4	4
Device Operates Differently Than Expected	4	4
Use of Device Problem	4	131
Incorrect Device Or Component Shipped	3	3
Device Handling Problem	3	3
Therapeutic or Diagnostic Output Failure	2	2
Insufficient Information	2	2
Appropriate Term/Code Not Available	2	2
Compatibility Problem	2	2
Material Discolored	2	2
Loose or Intermittent Connection	2	2
Nonstandard Device	2	2
Device Emits Odor	1	1
Use of Incorrect Control/Treatment Settings	1	1
Degraded	1	1
Display or Visual Feedback Problem	1	1
Fitting Problem	1	1
Loss of Osseointegration	1	1
Defective Device	1	1
Patient-Device Incompatibility	1	1
Patient Device Interaction Problem	1	1
Separation Problem	1	1
Unintended Compatibility	1	1
Material Deformation	1	1
Packaging Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Device Embedded In Tissue or Plaque	1487	1844
Insufficient Information	434	434
No Known Impact Or Consequence To Patient	404	404
No Information	265	702
Foreign Body In Patient	235	579
No Clinical Signs, Symptoms or Conditions	233	233
No Consequences Or Impact To Patient	118	555
Injury	41	41
Apicectomy	15	22
No Code Available	12	12
Pain	9	136
Tooth Fracture	7	7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	5	5
Sensitivity of Teeth	4	4
Unspecified Tissue Injury	3	3
Abrasion	3	3
Failure of Implant	2	2
Swelling/ Edema	2	2
Numbness	2	2
No Patient Involvement	2	2
Needle Stick/Puncture	1	1
Inflammation	1	1
Swelling	1	1
Tissue Damage	1	1
Reaction	1	1
Sinus Perforation	1	1
Discomfort	1	1