TPLC - Total Product Life Cycle

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

Premarket Reviews
Manufacturer	Decision
ATRIUM MEDICAL CORP.
	SUBSTANTIALLY EQUIVALENT	2
ATRIUM MEDICAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
C.R. BARD INC.
	SUBSTANTIALLY EQUIVALENT	3
C.R. BARD, INC.
	SUBSTANTIALLY EQUIVALENT	13
COVIDIEN LLC
	SUBSTANTIALLY EQUIVALENT	6
ETHICON
	SUBSTANTIALLY EQUIVALENT	6
ETHICON INC.
	SUBSTANTIALLY EQUIVALENT	1
ETHICON, INC
	SUBSTANTIALLY EQUIVALENT	1
ETHICON, INC.
	SUBSTANTIALLY EQUIVALENT	4
INTERNATIONAL LIFE SCIENCES
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC INC.
	SUBSTANTIALLY EQUIVALENT	5
MEDTRONIC, INC.
	SUBSTANTIALLY EQUIVALENT	4
PROXY BIOMEDICAL LTD
	SUBSTANTIALLY EQUIVALENT	1
PROXY BIOMEDICAL LTD.
	SUBSTANTIALLY EQUIVALENT	1
W.L. GORE & ASSOCIATES,INC
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Insufficient Information	26312
Defective Device	25001
Adverse Event Without Identified Device or Use Problem	16089
Appropriate Term/Code Not Available	2735
Migration or Expulsion of Device	2573
Patient Device Interaction Problem	760
Loss of or Failure to Bond	497
Material Erosion	449
Material Split, Cut or Torn	363
Material Deformation	352
Material Integrity Problem	307
Detachment of Device or Device Component	221
Material Perforation	149
Degraded	131
Break	122
Material Separation	101
Torn Material	95
Migration	77
No Apparent Adverse Event	60
Use of Device Problem	60
Product Quality Problem	58
Hole In Material	51
Failure To Adhere Or Bond	48
Tear, Rip or Hole in Device Packaging	46
Extrusion	45
Folded	42
Material Protrusion/Extrusion	28
Other (for use when an appropriate device code cannot be identified)	28
Detachment Of Device Component	27
Unsealed Device Packaging	26
Material Frayed	23
Packaging Problem	23
Device Markings/Labelling Problem	21
Expiration Date Error	20
Contamination	18
Material Disintegration	18
Material Too Rigid or Stiff	13
Shelf Life Exceeded	13
Material Rupture	13
Device Expiration Issue	13
Deformation Due to Compressive Stress	13
Device Contamination with Chemical or Other Material	12
Peeled/Delaminated	11
Delamination	11
Human-Device Interface Problem	10
Entrapment of Device	10
Patient-Device Incompatibility	9
Incorrect, Inadequate or Imprecise Resultor Readings	9
Mechanics Altered	8
Improper or Incorrect Procedure or Method	8
Obstruction of Flow	7
Device Issue	7
Device Damaged by Another Device	7
Sticking	6
Device Operates Differently Than Expected	6
Material Puncture/Hole	6
Device Appears to Trigger Rejection	6
Loosening of Implant Not Related to Bone-Ingrowth	5
Device Dislodged or Dislocated	5
Off-Label Use	5
Difficult to Open or Close	5
Device Slipped	4
Material Fragmentation	4
Microbial Contamination of Device	4
Bent	3
Split	3
Kinked	3
Difficult or Delayed Positioning	3
Structural Problem	2
Incomplete or Missing Packaging	2
Explanted	2
Difficult To Position	2
Component Missing	2
Impedance Problem	2
Inflation Problem	2
Misassembled	2
Unexpected Therapeutic Results	2
Unraveled Material	2
Inadequacy of Device Shape and/or Size	2
Device Or Device Fragments Location Unknown	1
Therapeutic or Diagnostic Output Failure	1
Out-Of-Box Failure	1
Inadequate Service	1
Ring	1
Crack	1
Device Reprocessing Problem	1
Device Contaminated During Manufacture or Shipping	1
Cut In Material	1
Material Twisted/Bent	1
Malfunction	1
Wrinkled	1
Failure to Auto Stop	1
Missing Value Reason	1
Incorrect Or Inadequate Test Results	1
Malposition of Device	1
Biocompatibility	1
Device Packaging Compromised	1
Incorrect Device Or Component Shipped	1
Material Distortion	1
Device Difficult to Maintain	1
Total Device Problems	77261

Recalls
Manufacturer		Recall Class	Date Posted
1	Atrium Medical Corporation	II	Feb-23-2018
2	Covidien LLC	II	Nov-14-2018
3	Covidien LLC	II	Jul-12-2018
4	EXP Pharmaceutical Services Corp	II	Jul-24-2015
5	MAST Biosurgery USA, Inc	II	Feb-10-2015
6	Novus Scientific Ab	II	Aug-19-2016
7	Sofradim Production	II	Apr-26-2018
8	Stryker Craniomaxillofacial Division	II	Feb-11-2015
9	TYRX Inc.	II	Aug-15-2016