TPLC - Total Product Life Cycle

• Device: mesh, surgical
• Regulation Description: Surgical mesh.
• Product Code: FTM
• Regulation Number: 878.3300
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
ALAFAIR BIOSCIENCES, INC.
	SUBSTANTIALLY EQUIVALENT	2
AROA BIOSURGERY , LTD.
	SUBSTANTIALLY EQUIVALENT	1
ELUTIA, INC.
	SUBSTANTIALLY EQUIVALENT	1
GEISTLICH PHARMA AG
	SUBSTANTIALLY EQUIVALENT	1
SYNOVIS LIFE TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
SYNOVIS LIFE TECHNOLOGIES. INC. (A SUBSIDIARY OF BAXTER
	SUBSTANTIALLY EQUIVALENT	1
TELA BIO
	SUBSTANTIALLY EQUIVALENT	1
TELA BIO, INC.
	SUBSTANTIALLY EQUIVALENT	2

MDR Year	MDR Reports	MDR Events
2021	369	370
2022	375	377
2023	485	487
2024	383	384
2025	233	233
2026	46	46

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	1341	1342
Patient Device Interaction Problem	119	119
Insufficient Information	98	98
Defective Device	91	91
Break	86	87
Patient-Device Incompatibility	80	80
Migration	34	35
Migration or Expulsion of Device	29	29
Material Disintegration	26	26
No Apparent Adverse Event	24	24
Peeled/Delaminated	17	17
Degraded	17	17
Mechanics Altered	15	15
Off-Label Use	11	11
Material Integrity Problem	11	11
Fluid/Blood Leak	9	9
Appropriate Term/Code Not Available	9	10
Material Split, Cut or Torn	9	9
Tear, Rip or Hole in Device Packaging	8	8
Material Deformation	7	7
Device Appears to Trigger Rejection	6	6
Improper or Incorrect Procedure or Method	5	5
Contamination /Decontamination Problem	4	4
Contamination	4	4
Therapeutic or Diagnostic Output Failure	4	4
Compatibility Problem	4	4
Malposition of Device	3	4
Material Discolored	2	2
Material Too Rigid or Stiff	2	3
Material Twisted/Bent	2	3
Material Puncture/Hole	2	2
Device Damaged Prior to Use	2	2
Material Separation	2	2
Detachment of Device or Device Component	2	2
Device Contamination with Chemical or Other Material	2	2
Entrapment of Device	2	2
Failure to Seal	2	2
Manufacturing, Packaging or Shipping Problem	1	1
Expiration Date Error	1	1
Defective Component	1	1
Material Fragmentation	1	1
Use of Device Problem	1	1
Material Perforation	1	1
Material Rupture	1	1
Inadequacy of Device Shape and/or Size	1	1
Material Protrusion/Extrusion	1	1
Separation Problem	1	1
Fracture	1	1
Device Contaminated During Manufacture or Shipping	1	1
Expulsion	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Hernia	860	861
Adhesion(s)	330	331
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	216	217
Pain	202	204
Seroma	186	187
Unspecified Infection	182	184
No Clinical Signs, Symptoms or Conditions	151	152
Obstruction/Occlusion	145	145
Bacterial Infection	144	144
Insufficient Information	143	143
Unspecified Tissue Injury	139	140
Abscess	129	129
Fistula	98	99
Impaired Healing	80	80
Fluid Discharge	77	77
Post Operative Wound Infection	73	73
Wound Dehiscence	67	68
Necrosis	63	64
Erosion	62	63
Inflammation	60	61
Hemorrhage/Bleeding	56	58
Abdominal Pain	46	46
Scar Tissue	42	42
Hematoma	37	38
Perforation	33	33
Discomfort	31	31
Failure of Implant	31	31
Cellulitis	27	27
Purulent Discharge	27	27
Foreign Body Reaction	25	25
Fever	23	23
Capsular Contracture	21	21
Swelling/ Edema	21	21
Erythema	20	20
Abdominal Distention	17	18
Incontinence	15	15
Vomiting	14	14
Skin Inflammation/ Irritation	13	13
Hypersensitivity/Allergic reaction	13	13
Nausea	13	13
Distress	12	12
Emotional Changes	12	12
Granuloma	12	12
Stenosis	11	11
Ascites	11	11
Urinary Tract Infection	10	10
Bowel Perforation	10	10
Prolapse	10	10
Sepsis	10	10
Muscle Weakness	9	9

Recalls
Manufacturer		Recall Class	Date Posted
1	Baxter Healthcare Corporation	II	Mar-26-2024
2	Baxter Healthcare Corporation	II	Jan-05-2024
3	Baxter Healthcare Corporation	II	Jan-08-2021
4	Cook Biotech, Inc.	II	Sep-25-2024
5	Stryker Leibinger GmbH & Co. KG	II	Mar-03-2022
6	TEI Biosciences, Inc.	II	Sep-30-2024