TPLC - Total Product Life Cycle

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Device	prosthesis, finger, constrained, polymer
Regulation Description	Finger joint polymer constrained prosthesis.
Product Code	KYJ
Regulation Number	888.3230
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	80	80
Fracture	40	40
Break	35	35
Device Dislodged or Dislocated	14	14
Naturally Worn	13	13
Unstable	8	8
Material Invagination	4	4
Patient-Device Incompatibility	4	4
Patient Device Interaction Problem	3	3
Inadequacy of Device Shape and/or Size	3	3
Insufficient Device Problem Information	3	3
Material Deformation	2	2
Material Split, Cut or Torn	2	2
Manufacturing, Packaging or Shipping Problem	1	1
Mechanical Problem	1	1
Loss of Osseointegration	1	1
Delivered as Unsterile Product	1	1
Loosening of Implant Not Related to Bone-Ingrowth	1	1
Degraded	1	1
Migration	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Failure of Implant	81	81
Insufficient Information	26	26
Implant Pain	20	20
Joint Laxity	15	15
No Clinical Signs, Symptoms or Conditions	14	14
Unspecified Infection	12	12
Joint Dislocation	9	9
Loss of Range of Motion	8	8
Deformity/ Disfigurement	4	4
Bone Fracture(s)	4	4
Swelling/ Edema	3	3
Pain	2	2
Limb Fracture	1	1
Fall	1	1
Arthralgia	1	1
Metal Related Pathology	1	1
Rheumatoid Arthritis	1	1
Damage to Ligament(s)	1	1
Foreign Body In Patient	1	1
Discomfort	1	1
Osteolysis	1	1
Nonunion/Delayed-union Bone Fracture	1	1
Aseptic loosening	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Osteotec Limited	II	Jul-31-2025