TPLC - Total Product Life Cycle

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

Device Problems	MDRs with this Device Problem	Events in those MDRs
Appropriate Term/Code Not Available	25	25
Migration	14	14
Adverse Event Without Identified Device or Use Problem	13	13
Device Appears to Trigger Rejection	4	4
Insufficient Information	3	3
Use of Device Problem	2	2
Expulsion	1	1
Peeled/Delaminated	1	1
Patient-Device Incompatibility	1	1
Contamination	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Impaired Healing	17	17
Swelling/ Edema	9	9
Pain	8	8
Wound Dehiscence	7	7
No Clinical Signs, Symptoms or Conditions	6	6
Bacterial Infection	5	5
Hypersensitivity/Allergic reaction	4	4
Peripheral Nervous Injury	4	4
Skin Infection	3	3
Post Operative Wound Infection	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Purulent Discharge	2	2
Post Traumatic Wound Infection	2	2
Fever	2	2
Erythema	2	2
Swollen Lymph Nodes/Glands	2	2
Unspecified Infection	1	1
Nausea	1	1
Failure of Implant	1	1
Skin Inflammation/ Irritation	1	1
Inflammation	1	1
Muscle Weakness	1	1
Adhesion(s)	1	1
Synovitis	1	1
Implant Pain	1	1
Foreign Body Reaction	1	1
Loss of Range of Motion	1	1
Numbness	1	1
Abscess	1	1
Fibrosis	1	1
Increased Sensitivity	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Baxter Healthcare Corporation	II	Apr-25-2023