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
BOSTON SCIENTIFIC
	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	139	139

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	1397	1399
Patient Device Interaction Problem	126	126
Insufficient Device Problem Information	107	107
Defective Device	90	90
Break	85	86
Patient-Device Incompatibility	80	80
Migration	35	36
Migration or Expulsion of Device	29	29
No Apparent Adverse Event	26	26
Material Disintegration	25	25
Peeled/Delaminated	17	17
Degraded	17	17
Mechanics Altered	15	15
Material Integrity Problem	13	13
Off-Label Use	11	11
Material Split, Cut or Torn	10	10
Fluid/Blood Leak	9	9
Device Appears to Trigger Rejection	8	8
Appropriate Device Problem Term/Code Not Available	8	9
Tear, Rip or Hole in Device Packaging	8	8
Material Deformation	8	8
Improper or Incorrect Procedure or Method	5	5
Compatibility Problem	4	4
Malposition of Device	4	4
Contamination /Decontamination Problem	4	4
Material Puncture/Hole	3	3
Failure to Seal	2	2
Device Contamination with Chemical or Other Material	2	2
Detachment of Device or Device Component	2	2
Material Separation	2	2
Lack of Effect	2	2
Material Twisted/Bent	2	3
Use of Device Problem	2	2
Material Discolored	2	2
Device Damaged Prior to Use	2	2
Material Too Rigid or Stiff	1	1
Material Perforation	1	1
Material Rupture	1	1
Material Fragmentation	1	1
Contamination	1	1
Therapeutic or Diagnostic Output Failure	1	1
Inadequacy of Device Shape and/or Size	1	1
Material Protrusion/Extrusion	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Expiration Date Error	1	1
Defective Component	1	1
Fracture	1	1
Melted	1	1
Failure to Form Staple	1	1
Separation Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Hernia	871	872
Adhesion(s)	340	341
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	224	225
Pain	208	210
Unspecified Infection	206	208
Seroma	201	202
No Clinical Signs, Symptoms or Conditions	156	157
Obstruction/Occlusion	151	151
Bacterial Infection	150	150
Insufficient Information	148	148
Unspecified Tissue Injury	141	142
Abscess	131	131
Fistula	101	102
Impaired Healing	82	82
Fluid Discharge	82	82
Post Operative Wound Infection	74	74
Wound Dehiscence	73	74
Necrosis	69	70
Inflammation	64	65
Erosion	63	64
Hemorrhage/Blood Loss/Bleeding	58	60
Abdominal Pain	51	51
Scar Tissue	47	47
Hematoma	41	42
Perforation	36	36
Discomfort	32	32
Cellulitis	32	32
Failure of Implant	31	31
Purulent Discharge	29	29
Fever	26	26
Capsular Contracture	26	26
Foreign Body Reaction	25	25
Erythema	23	23
Swelling/ Edema	21	21
Abdominal Distention	20	21
Vomiting	18	18
Nausea	17	17
Emotional Changes	15	15
Hypersensitivity/Allergic reaction	15	15
Incontinence	15	15
Skin Inflammation/ Irritation	14	14
Distress	13	13
Ascites	12	12
Granuloma	12	12
Medical device site infection	11	11
Dysphagia/ Odynophagia	11	11
Stenosis	11	11
Unspecified Gastrointestinal Problem	11	11
Sepsis	11	11
Urinary Tract Infection	11	11

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