TPLC - Total Product Life Cycle

• Device: cuff, nerve
• Product Code: JXI
• Regulation Number: 882.5275
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
ALAFAIR BIOSCIENCES INC
	SUBSTANTIALLY EQUIVALENT	2
AXOGEN CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
BIOCIRCUIT TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
BIOCIRCUIT TECHNOLOGIES, INCORPORATED
	SUBSTANTIALLY EQUIVALENT	1
CELESTRAY BIOTECH COMPANY, LLC.,
	SUBSTANTIALLY EQUIVALENT	1
MOCHIDA PHARMACEUTICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
MONARCH BIOIMPLANTS GMBH
	SUBSTANTIALLY EQUIVALENT	1
RENERVE LTD
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2019	10	10
2020	5	5
2021	3	3
2022	8	8
2023	15	15
2024	8	8

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	18	18
Migration	13	13
Appropriate Term/Code Not Available	7	7
Use of Device Problem	2	2
Device Appears to Trigger Rejection	2	2
Peeled/Delaminated	1	1
Patient-Device Incompatibility	1	1
Insufficient Information	1	1
Contamination	1	1
Failure to Fold	1	1
Inadequacy of Device Shape and/or Size	1	1
No Apparent Adverse Event	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Impaired Healing	14	14
No Clinical Signs, Symptoms or Conditions	6	6
Peripheral Nervous Injury	4	4
Inflammation	3	3
Pain	3	3
Skin Infection	2	2
No Code Available	2	2
Purulent Discharge	2	2
Post Operative Wound Infection	2	2
Injury	2	2
Fever	2	2
Numbness	2	2
Swelling	2	2
Swelling/ Edema	2	2
Unspecified Infection	1	1
Tingling	1	1
Hypersensitivity/Allergic reaction	1	1
Wound Dehiscence	1	1
Skin Irritation	1	1
Failure of Implant	1	1
Nausea	1	1
Skin Inflammation/ Irritation	1	1
Synovitis	1	1
Post Traumatic Wound Infection	1	1
Erythema	1	1
Abscess	1	1
Bacterial Infection	1	1
Granuloma	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Baxter Healthcare Corporation	II	Apr-25-2023
2	Integra LifeSciences Corp.	III	Mar-11-2020