TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
ALAFAIR BIOSCIENCES, INC.
	SUBSTANTIALLY EQUIVALENT	2
AROA BIOSURGERY , LTD.
	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	1350	1351
Patient Device Interaction Problem	121	121
Insufficient Information	103	103
Defective Device	91	91
Break	86	87
Patient-Device Incompatibility	80	80
Migration	36	37
Migration or Expulsion of Device	29	29
Material Disintegration	26	26
No Apparent Adverse Event	24	24
Peeled/Delaminated	17	17
Degraded	17	17
Mechanics Altered	15	15
Off-Label Use	11	11
Material Integrity Problem	11	11
Fluid/Blood Leak	9	9
Appropriate Term/Code Not Available	9	10
Material Split, Cut or Torn	9	9
Device Appears to Trigger Rejection	8	8
Tear, Rip or Hole in Device Packaging	8	8
Material Deformation	8	8
Improper or Incorrect Procedure or Method	5	5
Contamination /Decontamination Problem	4	4
Contamination	4	4
Therapeutic or Diagnostic Output Failure	4	4
Compatibility Problem	4	4
Malposition of Device	3	4
Material Discolored	2	2
Material Too Rigid or Stiff	2	3
Material Twisted/Bent	2	3
Material Puncture/Hole	2	2
Device Damaged Prior to Use	2	2
Material Separation	2	2
Detachment of Device or Device Component	2	2
Device Contamination with Chemical or Other Material	2	2
Entrapment of Device	2	2
Failure to Seal	2	2
Manufacturing, Packaging or Shipping Problem	1	1
Expiration Date Error	1	1
Defective Component	1	1
Material Fragmentation	1	1
Use of Device Problem	1	1
Material Perforation	1	1
Material Rupture	1	1
Inadequacy of Device Shape and/or Size	1	1
Material Protrusion/Extrusion	1	1
Separation Problem	1	1
Fracture	1	1
Device Contaminated During Manufacture or Shipping	1	1
Expulsion	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Hernia	862	863
Adhesion(s)	332	333
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	219	220
Pain	203	205
Seroma	188	189
Unspecified Infection	186	188
No Clinical Signs, Symptoms or Conditions	151	152
Bacterial Infection	145	145
Insufficient Information	145	145
Obstruction/Occlusion	145	145
Unspecified Tissue Injury	139	140
Abscess	130	130
Fistula	98	99
Impaired Healing	82	82
Fluid Discharge	78	78
Post Operative Wound Infection	73	73
Wound Dehiscence	67	68
Inflammation	63	64
Necrosis	63	64
Erosion	62	63
Hemorrhage/Bleeding	57	59
Abdominal Pain	50	50
Scar Tissue	46	46
Hematoma	37	38
Perforation	36	36
Discomfort	31	31
Failure of Implant	31	31
Cellulitis	30	30
Purulent Discharge	27	27
Fever	26	26
Foreign Body Reaction	25	25
Capsular Contracture	23	23
Erythema	21	21
Swelling/ Edema	21	21
Abdominal Distention	20	21
Vomiting	17	17
Nausea	16	16
Emotional Changes	15	15
Incontinence	15	15
Hypersensitivity/Allergic reaction	14	14
Skin Inflammation/ Irritation	13	13
Granuloma	12	12
Distress	12	12
Ascites	11	11
Stenosis	11	11
Bowel Perforation	10	10
Urinary Tract Infection	10	10
Sepsis	10	10
Prolapse	10	10
Constipation	9	9

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