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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device prosthesis, toe, constrained, polymer
Regulation Description Toe joint polymer constrained prosthesis.
Product CodeKWH
Regulation Number 888.3720
Device Class 2

MDR Year MDR Reports MDR Events
2021 5 5
2022 5 5
2023 6 6
2024 2 2
2025 9 9
2026 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 14 14
Break 4 4
Fracture 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
Patient-Device Incompatibility 1 1
Degraded 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 6 6
Post Operative Wound Infection 6 6
Implant Pain 5 5
Osteolysis 3 3
Pain 3 3
Swelling/ Edema 3 3
Insufficient Information 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
Foreign Body In Patient 1 1
Muscular Rigidity 1 1
Discomfort 1 1
Fall 1 1
Joint Laxity 1 1

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