TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
ALAFAIR BIOSCIENCES INC
	SUBSTANTIALLY EQUIVALENT	3
AROA BIOSURGERY LTD.
	SUBSTANTIALLY EQUIVALENT	1
AZIYO BIOLOGICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
B. BRUAN SURGICAL, SA
	SUBSTANTIALLY EQUIVALENT	1
COOK BIOTECH INCORPORATED
	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

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	1641	1641
Patient Device Interaction Problem	145	145
Insufficient Information	127	127
Defective Device	105	105
Break	89	89
Patient-Device Incompatibility	66	66
Migration or Expulsion of Device	60	60
Migration	33	33
No Apparent Adverse Event	23	23
Mechanics Altered	22	22
Material Disintegration	21	21
Degraded	21	21
Peeled/Delaminated	17	17
Material Split, Cut or Torn	16	16
Material Integrity Problem	15	15
Off-Label Use	10	10
Fluid/Blood Leak	9	9
Appropriate Term/Code Not Available	9	9
Detachment of Device or Device Component	8	8
Tear, Rip or Hole in Device Packaging	8	8
Improper or Incorrect Procedure or Method	7	7
Material Deformation	7	7
Therapeutic or Diagnostic Output Failure	6	6
Contamination /Decontamination Problem	5	5
Compatibility Problem	4	4
Contamination	3	3
Malposition of Device	3	3
Material Separation	3	3
Device Appears to Trigger Rejection	2	2
Manufacturing, Packaging or Shipping Problem	2	2
Material Discolored	2	2
Material Too Rigid or Stiff	2	2
Use of Device Problem	2	2
Material Twisted/Bent	2	2
Device Damaged Prior to Use	2	2
Product Quality Problem	2	2
Entrapment of Device	2	2
Melted	1	1
Unexpected Therapeutic Results	1	1
Failure to Form Staple	1	1
Fracture	1	1
Difficult to Open or Close	1	1
Failure to Seal	1	1
Material Protrusion/Extrusion	1	1
Device Contamination with Chemical or Other Material	1	1
Inadequacy of Device Shape and/or Size	1	1
Material Rupture	1	1
Material Perforation	1	1
Shipping Damage or Problem	1	1
Material Fragmentation	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Hernia	936	936
Adhesion(s)	401	401
Unspecified Infection	280	280
Pain	275	275
Injury	216	216
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	190	190
Seroma	190	190
Unspecified Tissue Injury	183	183
Obstruction/Occlusion	159	159
Abscess	153	153
No Clinical Signs, Symptoms or Conditions	149	149
Insufficient Information	142	142
Bacterial Infection	140	140
Fistula	120	120
Impaired Healing	97	97
Inflammation	85	85
Necrosis	85	85
Fluid Discharge	82	82
Wound Dehiscence	75	75
Failure of Implant	69	69
Erosion	67	67
Hemorrhage/Bleeding	67	67
Abdominal Pain	65	65
Post Operative Wound Infection	65	65
No Code Available	61	61
Scar Tissue	51	51
Discomfort	46	46
Purulent Discharge	43	43
Hematoma	43	43
Foreign Body Reaction	40	40
Perforation	38	38
Fever	34	34
Sepsis	32	32
Abdominal Distention	30	30
Cellulitis	28	28
Erythema	25	25
Incontinence	23	23
Hypersensitivity/Allergic reaction	22	22
Swelling/ Edema	21	21
Urinary Tract Infection	20	20
Nausea	20	20
Capsular Contracture	19	19
Vomiting	19	19
Ascites	17	17
Fibrosis	17	17
Emotional Changes	15	15
Scarring	15	15
Stenosis	14	14
Discharge	14	14
Prolapse	14	14

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