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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device bone wedge
Regulation Description Single/multiple component metallic bone fixation appliances and accessories.
Definition Intended to be used with ancillary fixation for opening wedge osteotomies or fusion in the ankle, foot, proximal tibia.
Product CodePLF
Regulation Number 888.3030
Device Class 2


Premarket Reviews
ManufacturerDecision
AMES MEDICAL PROSTHETIC SOLUTIONS, S.A.U.
  SUBSTANTIALLY EQUIVALENT 1
NVISION BIOMEDICAL TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 2
NVISION BIOMEDICAL TECHNOLOGIES, INC
  SUBSTANTIALLY EQUIVALENT 2
NVISION BIOMEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
PARAGON 28 INC
  SUBSTANTIALLY EQUIVALENT 1
RESTOR3D, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 3 3
2021 2 2
2022 4 4
2023 4 4
2024 3 3
2025 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 9 9
Break 5 5
Material Disintegration 1 1
Entrapment of Device 1 1
Fracture 1 1
Malposition of Device 1 1
Device Dislodged or Dislocated 1 1
Insufficient Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 5 5
No Clinical Signs, Symptoms or Conditions 3 3
Pain 3 3
Unspecified Infection 2 2
Failure of Implant 1 1
Implant Pain 1 1
Foreign Body In Patient 1 1
Swelling 1 1
Arthritis 1 1
Device Embedded In Tissue or Plaque 1 1

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