TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
ALAFAIR BIOSCIENCES INC
	SUBSTANTIALLY EQUIVALENT	3
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	1542	1543
Patient Device Interaction Problem	134	134
Insufficient Information	122	122
Defective Device	103	103
Break	88	88
Patient-Device Incompatibility	63	63
Migration or Expulsion of Device	58	58
Migration	29	29
Degraded	19	19
Mechanics Altered	18	18
No Apparent Adverse Event	17	17
Peeled/Delaminated	16	16
Material Disintegration	16	16
Material Split, Cut or Torn	15	15
Material Integrity Problem	15	15
Detachment of Device or Device Component	8	8
Fluid/Blood Leak	8	8
Appropriate Term/Code Not Available	8	8
Tear, Rip or Hole in Device Packaging	7	7
Material Deformation	7	7
Improper or Incorrect Procedure or Method	6	6
Off-Label Use	6	6
Therapeutic or Diagnostic Output Failure	6	6
Contamination /Decontamination Problem	5	5
Compatibility Problem	4	4
Material Separation	3	3
Contamination	2	2
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
Malposition of Device	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	892	893
Adhesion(s)	365	366
Unspecified Infection	264	265
Pain	259	260
Injury	216	216
Seroma	175	175
Unspecified Tissue Injury	175	176
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	148	148
Insufficient Information	142	142
No Clinical Signs, Symptoms or Conditions	142	142
Abscess	141	142
Obstruction/Occlusion	134	134
Bacterial Infection	133	133
Fistula	108	108
Impaired Healing	85	85
Necrosis	79	79
Inflammation	76	76
Fluid Discharge	75	75
Wound Dehiscence	70	70
Failure of Implant	64	64
Abdominal Pain	62	62
No Code Available	61	61
Hemorrhage/Bleeding	58	58
Erosion	56	56
Post Operative Wound Infection	52	52
Discomfort	44	44
Scar Tissue	44	44
Purulent Discharge	41	41
Foreign Body Reaction	38	38
Hematoma	38	38
Sepsis	32	32
Fever	31	31
Abdominal Distention	31	31
Cellulitis	25	25
Erythema	23	23
Incontinence	23	23
Urinary Tract Infection	20	20
Nausea	20	21
Hypersensitivity/Allergic reaction	20	20
Swelling/ Edema	20	20
Capsular Contracture	18	18
Vomiting	17	17
Fibrosis	17	17
Perforation	17	17
Ascites	16	16
Scarring	15	15
Discharge	14	14
Emotional Changes	14	14
Prolapse	14	14
Bowel Perforation	12	12

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