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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device bone wedge
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
ADDITIVE DEVICE, INC. (ADI) D/B/A RESTOR3D
  SUBSTANTIALLY EQUIVALENT 1
NVISION BIOMEDICAL TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 2
NVISION BIOMEDICAL TECHNOLOGIES, INC
  SUBSTANTIALLY EQUIVALENT 2
NVISION BIOMEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 3
PARAGON 28 INC
  SUBSTANTIALLY EQUIVALENT 1
RESTOR3D, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 2 2
2020 3 3
2021 2 2
2022 4 4
2023 4 4
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 8 8
Break 6 6
Entrapment of Device 1 1
Malposition of Device 1 1
Material Disintegration 1 1
Insufficient Information 1 1
Contamination /Decontamination Problem 1 1
Fracture 1 1
Device Dislodged or Dislocated 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 4 4
No Clinical Signs, Symptoms or Conditions 3 3
Insufficient Information 3 3
Unspecified Infection 2 2
Failure of Implant 1 1
No Code Available 1 1
Implant Pain 1 1
Foreign Body In Patient 1 1
Swelling 1 1
Bacterial Infection 1 1
Arthritis 1 1
Device Embedded In Tissue or Plaque 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Paragon 28, Inc. II Dec-10-2019
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