TPLC - Total Product Life Cycle

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Device	prosthesis, toe, constrained, polymer
Regulation Description	Toe joint polymer constrained prosthesis.
Product Code	KWH
Regulation Number	888.3720
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	15	15
Fracture	5	5
Break	4	4
Insufficient Information	2	2
Material Integrity Problem	2	2
Loosening of Implant Not Related to Bone-Ingrowth	2	2
Device Dislodged or Dislocated	2	2
Migration or Expulsion of Device	1	1
Crack	1	1
Patient-Device Incompatibility	1	1
Degraded	1	1
Failure to Align	1	1
Migration	1	1
Appropriate Term/Code Not Available	1	1
Inaccurate Information	1	1
Loss of Osseointegration	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Failure of Implant	7	7
Implant Pain	5	5
Post Operative Wound Infection	5	5
No Known Impact Or Consequence To Patient	4	4
Osteolysis	3	3
Pain	3	3
Discomfort	2	2
Swelling/ Edema	2	2
Unspecified Infection	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Hypersensitivity/Allergic reaction	1	1
Joint Dislocation	1	1
Inadequate Osseointegration	1	1
No Clinical Signs, Symptoms or Conditions	1	1
Bone Fracture(s)	1	1
Osteopenia/ Osteoporosis	1	1
Injury	1	1
Foreign Body In Patient	1	1
Muscular Rigidity	1	1
No Patient Involvement	1	1
Insufficient Information	1	1
Fall	1	1
Joint Laxity	1	1