TPLC - Total Product Life Cycle

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Device	suture, nonabsorbable, synthetic, polyethylene
Regulation Description	Nonabsorbable poly(ethylene terephthalate) surgical suture.
Product Code	GAT
Regulation Number	878.5000
Device Class	2

Premarket Reviews
Manufacturer	Decision
ALLOSOURCE
	SUBSTANTIALLY EQUIVALENT	1
ARCURO MEDICAL , LTD.
	SUBSTANTIALLY EQUIVALENT	1
ARTHREX, INC.
	SUBSTANTIALLY EQUIVALENT	4
CONMED CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
CYNOSURE, LLC
	SUBSTANTIALLY EQUIVALENT	1
EMBODY, INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDACTA INTERNATIONAL S.A.
	SUBSTANTIALLY EQUIVALENT	1
MEDOS INTERNATIONAL SARL
	SUBSTANTIALLY EQUIVALENT	2
RIVERPOINT MEDICAL
	SUBSTANTIALLY EQUIVALENT	3
RTI SURGICAL, INC.
	SUBSTANTIALLY EQUIVALENT	2
S.B.M. SAS (SCIENCE & BIO MATERIALS)
	SUBSTANTIALLY EQUIVALENT	1
SHANDONG HAIDIKE MEDICAL PRODUCTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SMITH & NEPHEW, INC.
	SUBSTANTIALLY EQUIVALENT	1
THREADSTONE, LLC
	SUBSTANTIALLY EQUIVALENT	4
WINTER INNOVATIONS, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Failure to Fire	2652	2652
Break	1681	1682
Firing Problem	1588	1589
Device Dislodged or Dislocated	1272	1272
Adverse Event Without Identified Device or Use Problem	1016	1017
Premature Activation	656	656
Material Separation	637	638
Physical Resistance/Sticking	476	476
Failure to Cycle	369	369
Detachment of Device or Device Component	366	367
Failure to Advance	163	163
Material Twisted/Bent	152	152
Material Split, Cut or Torn	105	105
Component Missing	73	73
Material Deformation	66	68
Insufficient Information	56	56
Material Frayed	51	51
Positioning Failure	47	47
Patient Device Interaction Problem	40	40
Unstable	40	40
Use of Device Problem	38	39
Product Quality Problem	38	38
Migration	37	38
Fracture	36	36
Unraveled Material	33	33
Delivered as Unsterile Product	33	33
Device Contaminated During Manufacture or Shipping	33	33
Component Misassembled	32	32
Mechanical Jam	30	31
Defective Device	27	27
Crack	26	26
Unintended Movement	24	24
Biocompatibility	22	22
Nonstandard Device	22	22
Material Fragmentation	21	21
Manufacturing, Packaging or Shipping Problem	19	19
Mechanical Problem	18	18
Device Slipped	18	18
Device Markings/Labelling Problem	17	18
Material Integrity Problem	17	17
Activation, Positioning or Separation Problem	16	16
Difficult to Advance	15	15
Packaging Problem	15	15
Human-Device Interface Problem	13	13
Activation Failure	13	13
Output Problem	12	13
Device Damaged Prior to Use	11	11
Appropriate Term/Code Not Available	9	9
Device-Device Incompatibility	8	8
Misfire	8	8

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	8908	8911
Insufficient Information	584	589
Device Embedded In Tissue or Plaque	511	511
Foreign Body In Patient	223	225
Unspecified Infection	222	222
Pain	172	174
Hemorrhage/Bleeding	116	116
Unspecified Tissue Injury	103	225
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	76	77
Wound Dehiscence	67	67
Failure of Implant	55	55
Granuloma	48	48
Post Operative Wound Infection	47	47
Swelling/ Edema	39	39
Hernia	38	38
Hematoma	37	37
Inflammation	37	37
Fluid Discharge	28	28
Fistula	27	27
Obstruction/Occlusion	26	26
Impaired Healing	26	26
Loss of Range of Motion	25	25
Fever	25	25
Pocket Erosion	24	24
Discomfort	23	23
Incontinence	23	23
Post Traumatic Wound Infection	22	22
Erosion	22	22
Abscess	21	23
Eye Injury	21	21
Sepsis	20	20
Adhesion(s)	20	20
Laceration(s)	19	19
Damage to Ligament(s)	18	18
Muscle/Tendon Damage	18	18
Scar Tissue	17	17
Urinary Tract Infection	16	16
Nerve Damage	16	16
Thrombosis/Thrombus	16	16
Failure to Anastomose	16	16
Perforation	16	16
Muscular Rigidity	15	15
Fibrosis	15	15
Rupture	14	14
Bacterial Infection	14	16
Necrosis	14	14
Erythema	14	16
Seroma	13	13
Purulent Discharge	13	15
Dysphagia/ Odynophagia	13	13

Recalls
Manufacturer		Recall Class	Date Posted
1	Covidien, LP	II	Feb-25-2023