TPLC - Total Product Life Cycle

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Device	prosthesis, toe, hemi-, phalangeal
Regulation Description	Toe joint phalangeal (hemi-toe) polymer prosthesis.
Product Code	KWD
Regulation Number	888.3730
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	121	121
Unintended Movement	31	31
Improper or Incorrect Procedure or Method	6	6
Insufficient Information	4	4
Off-Label Use	4	4
No Apparent Adverse Event	3	3
Loosening of Implant Not Related to Bone-Ingrowth	3	3
Use of Device Problem	2	2
Difficult to Insert	2	2
Degraded	1	1
Material Fragmentation	1	1
Migration	1	1
Loss of Osseointegration	1	1
Defective Device	1	2
Malposition of Device	1	1
Device Dislodged or Dislocated	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Insufficient Information	64	64
Implant Pain	46	46
Failure of Implant	20	20
Pain	20	20
Loss of Range of Motion	13	13
Unspecified Infection	6	6
Osteolysis	4	4
Deformity/ Disfigurement	4	4
No Clinical Signs, Symptoms or Conditions	3	4
Swelling/ Edema	3	3
Inadequate Pain Relief	3	3
Inadequate Osseointegration	2	2
Arthritis	2	2
Skin Infection	1	1
Joint Dislocation	1	1
Wound Dehiscence	1	1
Metal Related Pathology	1	1
Bone Fracture(s)	1	1
Reaction to Medicinal Component of Device	1	1
Swelling	1	1
Subluxation	1	1
Ambulation Difficulties	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	BioPro, Inc.	II	Feb-28-2022