TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
ALAFAIR BIOSCIENCES INC
	SUBSTANTIALLY EQUIVALENT	2
AXOGEN CORPORATION
	SUBSTANTIALLY EQUIVALENT	3
BIOCIRCUIT TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
BIOCIRCUIT TECHNOLOGIES, INCORPORATED
	SUBSTANTIALLY EQUIVALENT	1
BIOM'UP SAS
	SUBSTANTIALLY EQUIVALENT	1
CELESTRAY BIOTECH COMPANY, LLC.,
	SUBSTANTIALLY EQUIVALENT	1
COLLAGEN MATRIX, INC.
	SUBSTANTIALLY EQUIVALENT	2
COOK BIOTECH INCORPORATED
	SUBSTANTIALLY EQUIVALENT	2
INTEGRA LIFESCIENCES CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
MEDOVENT GMBH
	SUBSTANTIALLY EQUIVALENT	2
MONARCH BIOIMPLANTS GMBH
	SUBSTANTIALLY EQUIVALENT	1
POLYGANICS BV
	SUBSTANTIALLY EQUIVALENT	1
POLYGANICS INNOVATIONS BV
	SUBSTANTIALLY EQUIVALENT	1
RENERVE LTD
	SUBSTANTIALLY EQUIVALENT	1
SALUMEDICA, L.L.C.
	SUBSTANTIALLY EQUIVALENT	1
TOYOBO CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	22	22
Migration	13	13
Insufficient Information	8	8
Appropriate Term/Code Not Available	8	8
Device Expiration Issue	6	6
Shelf Life Exceeded	6	6
Patient-Device Incompatibility	5	5
Device Operates Differently Than Expected	3	3
Device Appears to Trigger Rejection	3	3
No Apparent Adverse Event	2	2
Use of Device Problem	2	2
Improper or Incorrect Procedure or Method	2	2
Expiration Date Error	1	1
Inadequacy of Device Shape and/or Size	1	1
Failure to Fold	1	1
Peeled/Delaminated	1	1
Contamination	1	1
Material Disintegration	1	1
Unintended Movement	1	1
Extrusion	1	1
Device Contamination with Chemical or Other Material	1	1
Device Handling Problem	1	1
Patient Device Interaction Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Impaired Healing	14	14
Swelling	12	12
No Known Impact Or Consequence To Patient	12	12
Inflammation	8	8
No Clinical Signs, Symptoms or Conditions	6	6
Unspecified Infection	5	5
Numbness	5	5
No Consequences Or Impact To Patient	5	5
Reaction	4	4
Post Operative Wound Infection	4	4
Peripheral Nervous Injury	4	4
Pain	4	4
Hypersensitivity/Allergic reaction	3	3
Wound Dehiscence	3	3
Bacterial Infection	3	3
Purulent Discharge	3	3
Erythema	3	3
Injury	3	3
Synovitis	3	3
Seroma	3	3
Skin Infection	2	2
Fluid Discharge	2	2
No Code Available	2	2
Fever	2	2
Failure of Implant	2	2
Granuloma	2	2
Swelling/ Edema	2	2
Staphylococcus Aureus	1	1
Scar Tissue	1	1
Irritation	1	1
Nausea	1	1
Foreign Body Reaction	1	1
Host-Tissue Reaction	1	1
Abscess	1	1
Adhesion(s)	1	1
Skin Inflammation/ Irritation	1	1
Post Traumatic Wound Infection	1	1
Fibrosis	1	1
Skin Irritation	1	1
Tingling	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Baxter Healthcare Corporation	II	Apr-25-2023
2	Integra LifeSciences Corp.	III	Mar-11-2020
3	Integra LifeSciences Corporation	II	May-10-2013