TPLC - Total Product Life Cycle

• Device: cuff, nerve
• Regulation Description: Nerve cuff.
• 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
RENERVE LTD
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2020	5	5
2021	3	3
2022	8	8
2023	15	15
2024	18	18

Device Problems	MDRs with this Device Problem	Events in those MDRs
Migration	14	14
Adverse Event Without Identified Device or Use Problem	13	13
Appropriate Term/Code Not Available	12	12
Insufficient Information	2	2
Use of Device Problem	2	2
Device Appears to Trigger Rejection	2	2
Peeled/Delaminated	1	1
Patient-Device Incompatibility	1	1
Contamination	1	1
Inadequacy of Device Shape and/or Size	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Impaired Healing	15	15
No Clinical Signs, Symptoms or Conditions	6	6
Wound Dehiscence	4	4
Peripheral Nervous Injury	4	4
Swelling/ Edema	4	4
Bacterial Infection	4	4
Skin Infection	3	3
Hypersensitivity/Allergic reaction	3	3
Pain	3	3
Failure of Implant	2	2
Purulent Discharge	2	2
Post Operative Wound Infection	2	2
Post Traumatic Wound Infection	2	2
Fever	2	2
Injury	2	2
Unspecified Infection	1	1
Nausea	1	1
Skin Inflammation/ Irritation	1	1
Inflammation	1	1
Foreign Body Reaction	1	1
Erythema	1	1
Loss of Range of Motion	1	1
Abscess	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