TPLC - Total Product Life Cycle

show TPLC since

Device	elastomer, silicone block
Regulation Description	Ear, nose, and throat synthetic polymer material.
Product Code	MIB
Regulation Number	874.3620
Device Class	2

Premarket Reviews
Manufacturer	Decision
AUGMENTA, LLC
	SUBSTANTIALLY EQUIVALENT	1
INTERNATIONAL MEDICAL DEVICES, INC.
	SUBSTANTIALLY EQUIVALENT	2
KEOSAN TRADING CO.
	SUBSTANTIALLY EQUIVALENT	1
SHINEO TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	33	33
Insufficient Information	20	21
Material Protrusion/Extrusion	20	20
Patient Device Interaction Problem	19	19
Use of Device Problem	16	17
Migration or Expulsion of Device	10	10
Patient-Device Incompatibility	6	6
Product Quality Problem	6	7
Malposition of Device	5	5
Inadequacy of Device Shape and/or Size	4	4
Device Appears to Trigger Rejection	4	4
Break	3	3
No Apparent Adverse Event	3	3
Defective Device	2	2
Material Fragmentation	2	2
Use of Incorrect Control/Treatment Settings	2	2
Material Rupture	2	2
Improper or Incorrect Procedure or Method	2	2
Material Integrity Problem	1	1
Positioning Problem	1	1
Microbial Contamination of Device	1	1
Difficult to Insert	1	2
Detachment of Device or Device Component	1	1
Migration	1	1
Fracture	1	1
Material Too Soft/Flexible	1	1
Deformation Due to Compressive Stress	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pain	60	60
Deformity/ Disfigurement	55	56
Swelling/ Edema	38	38
Failure of Implant	37	38
Scar Tissue	31	32
Seroma	25	26
Decreased Sensitivity	19	19
Erosion	17	17
Implant Pain	12	12
Unspecified Infection	11	11
Sexual Dysfunction	11	11
Capsular Contracture	11	12
Inflammation	10	10
Fluid Discharge	9	9
Post Operative Wound Infection	9	9
Depression	9	9
Skin Erosion	8	8
Erectile Dysfunction	8	8
Nerve Damage	6	6
Numbness	6	6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	5	5
Wound Dehiscence	5	5
Dysuria	5	5
Bacterial Infection	5	5
Unspecified Tissue Injury	5	5
Wrinkling	5	5
Insufficient Information	5	7
Emotional Changes	4	4
Ecchymosis	4	4
Fibrosis	3	3
Sore Throat	3	3
Blister	3	3
Hematoma	3	3
Foreign Body Reaction	2	2
Perforation	2	2
Skin Inflammation/ Irritation	2	2
Nausea	2	2
Drug Resistant Bacterial Infection	2	2
Impaired Healing	2	2
Discomfort	1	1
Cellulitis	1	1
Abrasion	1	1
Adhesion(s)	1	1
Genital Bleeding	1	1
Fungal Infection	1	1
Skin Infection	1	1
Unspecified Vascular Problem	1	1
Pocket Erosion	1	1
Urinary Tract Infection	1	1
Distress	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	DSAART LLC	II	Dec-18-2025