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
KLISBIO S.R.L.
	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 Device Problem Term/Code Not Available	25	25
Adverse Event Without Identified Device or Use Problem	22	22
Migration	15	15
Device Appears to Trigger Rejection	4	4
Insufficient Device Problem Information	3	3
Use of Device Problem	2	2
Expulsion	2	2
Contamination	1	1
Peeled/Delaminated	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Impaired Healing	17	17
Pain	11	11
Swelling/ Edema	10	10
Wound Dehiscence	9	9
No Clinical Signs, Symptoms or Conditions	6	6
Bacterial Infection	5	5
Inflammation	5	5
Hypersensitivity/Allergic reaction	4	4
Peripheral Nervous Injury	4	4
Purulent Discharge	3	3
Skin Infection	3	3
Erythema	3	3
Post Operative Wound Infection	3	3
Seroma	2	2
Paresthesia	2	2
Wound Infection	2	2
Swollen Lymph Nodes/Glands	2	2
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	2	2
Fever	2	2
Skin Inflammation/ Irritation	2	2
Hyperresponsive to stimuli	1	1
Synovitis	1	1
Adhesion(s)	1	1
Neuralgia	1	1
Implant Pain	1	1
Abscess	1	1
Failure of Implant	1	1
Abnormal scarring	1	1
Loss of Range of Motion	1	1
Unspecified Infection	1	1
Fibrosis	1	1
Numbness	1	1
Foreign Body Reaction	1	1
Muscle Weakness/Atrophy	1	1
Nausea	1	1
Sinusitis	1	1

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