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	1690	1690
Patient Device Interaction Problem	147	147
Insufficient Information	130	130
Defective Device	105	105
Break	88	88
Patient-Device Incompatibility	78	78
Migration or Expulsion of Device	60	60
Migration	34	34
No Apparent Adverse Event	23	23
Mechanics Altered	23	23
Degraded	23	23
Material Disintegration	21	21
Peeled/Delaminated	17	17
Material Split, Cut or Torn	16	16
Material Integrity Problem	15	15
Off-Label Use	11	11
Fluid/Blood Leak	9	9
Material Deformation	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
Therapeutic or Diagnostic Output Failure	6	6
Contamination /Decontamination Problem	5	5
Device Appears to Trigger Rejection	4	4
Compatibility Problem	4	4
Contamination	3	3
Material Separation	3	3
Malposition of Device	3	4
Material Discolored	2	2
Material Too Rigid or Stiff	2	3
Use of Device Problem	2	2
Material Twisted/Bent	2	2
Manufacturing, Packaging or Shipping Problem	2	2
Material Puncture/Hole	2	2
Device Damaged Prior to Use	2	2
Product Quality Problem	2	2
Entrapment of Device	2	2
Unexpected Therapeutic Results	1	1
Failure to Form Staple	1	1
Melted	1	1
Difficult to Open or Close	1	1
Fracture	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

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Hernia	955	955
Adhesion(s)	420	420
Unspecified Infection	288	288
Pain	281	281
Injury	215	215
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	207	207
Seroma	202	202
Unspecified Tissue Injury	187	187
Obstruction/Occlusion	171	171
Abscess	163	163
No Clinical Signs, Symptoms or Conditions	150	150
Bacterial Infection	148	148
Insufficient Information	144	144
Fistula	123	123
Impaired Healing	103	103
Fluid Discharge	91	91
Inflammation	87	87
Necrosis	85	85
Wound Dehiscence	80	80
Post Operative Wound Infection	74	74
Abdominal Pain	70	70
Erosion	69	69
Failure of Implant	69	69
Hemorrhage/Bleeding	68	69
No Code Available	61	61
Scar Tissue	54	54
Discomfort	48	48
Hematoma	47	47
Purulent Discharge	44	44
Foreign Body Reaction	41	41
Perforation	38	38
Cellulitis	34	34
Fever	34	34
Abdominal Distention	32	32
Sepsis	32	32
Erythema	26	26
Capsular Contracture	24	24
Incontinence	23	23
Swelling/ Edema	23	23
Vomiting	22	22
Nausea	22	22
Hypersensitivity/Allergic reaction	22	22
Urinary Tract Infection	20	20
Ascites	18	18
Emotional Changes	17	17
Fibrosis	17	17
Distress	17	17
Granuloma	16	16
Scarring	15	15
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