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	6
CONMED CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
CYNOSURE, LLC
	SUBSTANTIALLY EQUIVALENT	1
EMBODY, INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDACTA INTERNATIONAL SA
	SUBSTANTIALLY EQUIVALENT	1
MEDOS INTERNATIONAL SARL
	SUBSTANTIALLY EQUIVALENT	2
RIVERPOINT MEDICAL
	SUBSTANTIALLY EQUIVALENT	3
RIVERPOINT MEDICAL, LLC
	SUBSTANTIALLY EQUIVALENT	1
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
TELEFLEX MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
THREADSTONE, LLC
	SUBSTANTIALLY EQUIVALENT	4
WINTER INNOVATIONS, INC.
	SUBSTANTIALLY EQUIVALENT	1
YUNYI (BEIJING) MEDICAL DEVICE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Failure to Fire	2695	2695
Break	1753	1755
Firing Problem	1742	1743
Device Dislodged or Dislocated	1218	1218
Adverse Event Without Identified Device or Use Problem	1091	1092
Material Separation	825	826
Premature Activation	668	668
Physical Resistance/Sticking	417	417
Detachment of Device or Device Component	367	368
Failure to Cycle	331	331
Failure to Advance	166	166
Material Twisted/Bent	137	137
Material Split, Cut or Torn	118	118
Insufficient Information	89	89
Component Missing	81	81
Unintended Ejection	70	70
Material Deformation	63	65
Material Frayed	54	54
Positioning Failure	54	54
Patient Device Interaction Problem	43	43
Migration	40	41
Unstable	40	40
Product Quality Problem	39	39
Mechanical Jam	36	37
Unraveled Material	36	36
Use of Device Problem	33	34
Device Contaminated During Manufacture or Shipping	32	32
Component Misassembled	32	32
Delivered as Unsterile Product	32	32
Defective Device	27	27
Mechanical Problem	26	26
Fracture	26	26
Crack	26	26
Material Integrity Problem	26	26
Manufacturing, Packaging or Shipping Problem	25	25
Nonstandard Device	24	24
Unintended Movement	24	24
Biocompatibility	22	22
Material Fragmentation	22	22
Device Markings/Labelling Problem	21	22
Device Slipped	21	21
Packaging Problem	21	21
Activation, Positioning or Separation Problem	19	19
Ejection Problem	15	15
Difficult to Advance	15	15
Activation Failure	14	14
Human-Device Interface Problem	13	13
Misfire	13	13
Output Problem	12	13
Appropriate Term/Code Not Available	11	11

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	8623	8627
Insufficient Information	580	585
Device Embedded In Tissue or Plaque	507	507
No Known Impact Or Consequence To Patient	417	417
Foreign Body In Patient	256	258
No Information	250	250
Unspecified Infection	233	233
Pain	197	199
No Consequences Or Impact To Patient	183	183
Hemorrhage/Bleeding	112	112
Unspecified Tissue Injury	102	224
Injury	79	79
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	78	79
Wound Dehiscence	70	70
Failure of Implant	57	57
Post Operative Wound Infection	51	51
Granuloma	48	48
Hernia	44	44
Not Applicable	44	44
Inflammation	43	43
Hematoma	41	41
Swelling/ Edema	39	39
No Code Available	38	38
Fistula	30	30
Obstruction/Occlusion	30	30
Fluid Discharge	28	28
Impaired Healing	28	28
Abscess	27	29
Fever	27	27
Incontinence	26	26
Adhesion(s)	25	25
Loss of Range of Motion	24	24
Erosion	24	24
Sepsis	23	23
Discomfort	23	23
Eye Injury	23	23
Pocket Erosion	23	23
Post Traumatic Wound Infection	22	22
Erythema	21	23
Scar Tissue	20	20
Nerve Damage	20	20
Laceration(s)	19	19
Damage to Ligament(s)	18	18
Muscle/Tendon Damage	17	17
Muscular Rigidity	17	17
Perforation	17	17
Urinary Tract Infection	17	17
Failure to Anastomose	16	16
Bacterial Infection	16	18
Fibrosis	16	16