TPLC - Total Product Life Cycle

• 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
ARTHEX, INC
	SUBSTANTIALLY EQUIVALENT	1
NVISION BIOMEDICAL TECHNOLOGIES
	SUBSTANTIALLY EQUIVALENT	1
NVISION BIOMEDICAL TECHNOLOGIES, INC
	SUBSTANTIALLY EQUIVALENT	2
NVISION BIOMEDICAL TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	3
PARAGON 28
	SUBSTANTIALLY EQUIVALENT	1
PARAGON 28 INC
	SUBSTANTIALLY EQUIVALENT	1
RESTOR3D, INC.
	SUBSTANTIALLY EQUIVALENT	1
TYBER MEDICAL LLC
	SUBSTANTIALLY EQUIVALENT	2

MDR Year	MDR Reports	MDR Events
2019	2	2
2020	3	3
2021	2	2
2022	4	4
2023	4	4
2024	1	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	7	7
Break	6	6
Material Disintegration	1	1
Entrapment of Device	1	1
Fracture	1	1
Malposition of Device	1	1
Contamination /Decontamination Problem	1	1
Device Dislodged or Dislocated	1	1
Insufficient Information	1	1

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

Recalls
Manufacturer		Recall Class	Date Posted
1	Arthrex, Inc.	II	Jun-14-2016
2	Paragon 28, Inc.	II	Dec-10-2019