TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	138	138
Fracture	25	25
Material Fragmentation	21	21
Detachment Of Device Component	13	13
Detachment of Device or Device Component	9	9
Component Missing	9	9
Contamination /Decontamination Problem	6	6
Material Integrity Problem	6	6
Material Separation	6	6
Material Deformation	5	5
Component Falling	5	5
Appropriate Term/Code Not Available	5	5
Device Fell	4	4
Material Twisted/Bent	4	4
Bent	4	4
Material Erosion	4	4
Loose or Intermittent Connection	4	4
Mechanical Problem	4	4
Peeled/Delaminated	4	4
Insufficient Information	3	3
Missing Value Reason	3	3
Device Operates Differently Than Expected	3	3
Compatibility Problem	3	3
Device Dislodged or Dislocated	3	3
Adverse Event Without Identified Device or Use Problem	2	2
Difficult to Remove	2	2
Device Or Device Fragments Location Unknown	2	2
Entrapment of Device	2	2
Device Slipped	1	1
Material Torqued	1	1
Corroded	1	1
Unstable	1	1
Material Discolored	1	1
Solder Joint Fracture	1	1
Device Inoperable	1	1
Delivered as Unsterile Product	1	1
Difficult to Open or Close	1	1
Structural Problem	1	1
Failure to Cut	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	89	89
No Clinical Signs, Symptoms or Conditions	59	59
No Consequences Or Impact To Patient	27	27
Foreign Body In Patient	24	24
No Patient Involvement	16	16
Insufficient Information	16	16
Device Embedded In Tissue or Plaque	12	12
No Information	7	7
No Code Available	7	7
Hemorrhage/Bleeding	3	3
Pain	2	2
Missing Value Reason	2	2
Patient Problem/Medical Problem	2	2
Unspecified Tissue Injury	1	1
Atrial Fibrillation	1	1
Failure of Implant	1	1
Nerve Damage	1	1
Injury	1	1
Deformity/ Disfigurement	1	1
Spinal Cord Injury	1	1
Ambulation Difficulties	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Exactech, Inc.	II	Jul-03-2017