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	16	16
Inadequacy of Device Shape and/or Size	7	7
Device Dislodged or Dislocated	4	4
Insufficient Information	3	3
Expulsion	2	2
Malposition of Device	2	2
Output Problem	2	2
Patient Device Interaction Problem	2	2
Fracture	2	2
Appropriate Term/Code Not Available	2	2
Device Appears to Trigger Rejection	2	2
Fitting Problem	1	1
Mechanical Problem	1	1
Migration or Expulsion of Device	1	1
Material Erosion	1	1
Patient-Device Incompatibility	1	1
Material Integrity Problem	1	1
Difficult to Remove	1	1
No Apparent Adverse Event	1	1
Mechanical Jam	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Unspecified Infection	13	13
No Clinical Signs, Symptoms or Conditions	11	11
Pain	5	5
Bacterial Infection	5	5
Impaired Healing	4	4
Insufficient Information	4	4
Fluid Discharge	3	3
Swelling/ Edema	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Failure of Implant	2	2
Skin Erosion	2	2
Pocket Erosion	2	2
Device Embedded In Tissue or Plaque	2	2
Cerebral Edema	2	2
Skin Infection	1	1
Wound Dehiscence	1	1
Inadequate Osseointegration	1	1
No Code Available	1	1
No Information	1	1
Inflammation	1	1
Purulent Discharge	1	1
Post Operative Wound Infection	1	1
Foreign Body In Patient	1	1
Loss of Range of Motion	1	1
Discomfort	1	1
Ecchymosis	1	1
Physical Asymmetry	1	1
Hemorrhage/Bleeding	1	1
Deformity/ Disfigurement	1	1
Airway Obstruction	1	1