TPLC - Total Product Life Cycle

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Device	suture, surgical, absorbable, polydioxanone
Regulation Description	Absorbable polydioxanone surgical suture.
Product Code	NEW
Regulation Number	878.4840
Device Class	2

Premarket Reviews
Manufacturer	Decision
ETHICON, INC.
	SUBSTANTIALLY EQUIVALENT	2
1. K192144 STRATAFIX Spiral PDS Plus Bidirectional Knotless T ...
2. K212380 PDS Plus Antibacterial (Polydioxanone) Sterile Syn ...
FOOSIN MEDICAL SUPPLIES INC., LTD.
	SUBSTANTIALLY EQUIVALENT	1
HANS BIOMED CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
HYUNDAE MEDITECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
M/S. MERIL ENDO SURGERY PRIVATE LIMITED
	SUBSTANTIALLY EQUIVALENT	1
PDO MAX, INC.
	SUBSTANTIALLY EQUIVALENT	1
SUTURION AB
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	4373	5105
Material Separation	1869	1869
Adverse Event Without Identified Device or Use Problem	1194	1438
Material Integrity Problem	290	290
Positioning Failure	238	238
Detachment of Device or Device Component	125	369
Patient Device Interaction Problem	116	238
Migration	71	71
Material Frayed	69	69
Defective Component	66	66
Device Markings/Labelling Problem	46	46
Delivered as Unsterile Product	46	46
Component Misassembled	44	44
Material Twisted/Bent	38	160
Material Protrusion/Extrusion	34	156
Material Split, Cut or Torn	31	31
Separation Problem	30	30
Device Contaminated During Manufacture or Shipping	25	25
Positioning Problem	22	22
Migration or Expulsion of Device	20	20
Appropriate Term/Code Not Available	18	18
Difficult to Open or Remove Packaging Material	18	18
Manufacturing, Packaging or Shipping Problem	18	18
Tear, Rip or Hole in Device Packaging	15	15
Device Appears to Trigger Rejection	14	14
Expulsion	12	12
Component Missing	9	9
Insufficient Information	7	7
Packaging Problem	7	7
Dull, Blunt	7	7
Material Fragmentation	6	6
Device Fell	6	6
Material Discolored	6	6
Difficult or Delayed Positioning	5	5
Material Deformation	5	5
Product Quality Problem	5	5
Patient-Device Incompatibility	4	4
Separation Failure	4	4
Inadequacy of Device Shape and/or Size	4	4
Entrapment of Device	4	4
Use of Device Problem	3	3
Degraded	2	2
Material Rupture	2	2
Crack	2	2
Incomplete or Missing Packaging	2	2
Device Slipped	2	2
Loose or Intermittent Connection	2	2
Defective Device	1	1
Therapeutic or Diagnostic Output Failure	1	1
Difficult to Remove	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	5888	6376
No Consequences Or Impact To Patient	678	678
Wound Dehiscence	588	832
Unspecified Infection	376	498
Insufficient Information	275	397
Pain	175	175
Hemorrhage/Bleeding	143	143
Hernia	108	108
Inflammation	99	99
Failure to Anastomose	93	93
Foreign Body In Patient	91	335
Hematoma	90	90
Fistula	86	86
Post Operative Wound Infection	86	208
Abscess	84	84
Impaired Healing	82	204
Not Applicable	80	80
Pocket Erosion	68	68
Fluid Discharge	68	190
Obstruction/Occlusion	68	68
Swelling/ Edema	67	67
Necrosis	65	65
Unspecified Tissue Injury	64	64
Discomfort	63	63
Seroma	61	61
Erythema	60	60
Purulent Discharge	55	55
Hypersensitivity/Allergic reaction	50	50
Skin Inflammation/ Irritation	49	49
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	45	167
Nodule	42	42
Scar Tissue	35	35
Fever	33	33
Sepsis	30	30
No Code Available	29	29
Granuloma	28	28
Foreign Body Reaction	26	26
Urinary Tract Infection	23	23
Itching Sensation	23	23
Joint Dislocation	21	21
Rupture	20	20
Incontinence	20	20
Local Reaction	19	19
Ulcer	19	19
Blood Loss	18	18
No Known Impact Or Consequence To Patient	17	17
Cellulitis	16	16
Thrombosis/Thrombus	13	13
Adhesion(s)	12	12
Urinary Retention	12	12