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TPLC - Total Product Life Cycle
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TPLC
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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 Code
PLF
Regulation Number
888.3030
Device Class
2
Premarket Reviews
Manufacturer
Decision
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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