TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	2353	2803
Material Separation	118	118
Difficult to Remove	93	93
Entrapment of Device	60	60
Detachment of Device or Device Component	39	39
Detachment Of Device Component	9	9
Fracture	8	8
Material Fragmentation	7	7
Material Integrity Problem	5	231
Adverse Event Without Identified Device or Use Problem	5	5
Use of Device Problem	4	131
Device Operates Differently Than Expected	4	4
Component Falling	4	4
Incorrect Device Or Component Shipped	3	3
Device Handling Problem	3	3
Compatibility Problem	2	2
Insufficient Information	2	2
Therapeutic or Diagnostic Output Failure	2	2
Material Discolored	2	2
Appropriate Term/Code Not Available	2	2
Nonstandard Device	2	2
Loose or Intermittent Connection	2	2
Fitting Problem	1	1
Separation Problem	1	1
Patient-Device Incompatibility	1	1
Unintended Movement	1	1
Defective Device	1	1
Patient Device Interaction Problem	1	1
Degraded	1	1
Unintended Compatibility	1	1
Use of Incorrect Control/Treatment Settings	1	1
Material Deformation	1	1
Packaging Problem	1	1
Device Emits Odor	1	1
Display or Visual Feedback Problem	1	1
Loss of Osseointegration	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Device Embedded In Tissue or Plaque	1583	1940
Insufficient Information	456	456
No Known Impact Or Consequence To Patient	404	404
No Information	265	702
No Clinical Signs, Symptoms or Conditions	242	242
Foreign Body In Patient	236	580
No Consequences Or Impact To Patient	118	555
Injury	41	41
Apicectomy	15	22
No Code Available	12	12
Pain	10	137
Tooth Fracture	7	7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	5	5
Sensitivity of Teeth	4	4
Abrasion	3	3
Needle Stick/Puncture	3	3
Unspecified Tissue Injury	3	3
Failure of Implant	2	2
Numbness	2	2
No Patient Involvement	2	2
Swelling/ Edema	2	2
Inflammation	1	1
Sinus Perforation	1	1
Swelling	1	1
Discomfort	1	1
Laceration(s)	1	1
Reaction	1	1
Tissue Damage	1	1
Hemorrhage/Bleeding	1	1