TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
CEREMED INC.
	SUBSTANTIALLY EQUIVALENT	1
CEREMED, INC.
	SUBSTANTIALLY EQUIVALENT	1
HEMOSTASIS, LLC
	SUBSTANTIALLY EQUIVALENT	1
M/S. MERIL ENDO SURGERY PRIVATE LIMITED
	SUBSTANTIALLY EQUIVALENT	1
MARINE POLYMER TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
ORTHOCON
	SUBSTANTIALLY EQUIVALENT	1
ORTHOCON, INC.
	SUBSTANTIALLY EQUIVALENT	18
ORTHOCON, LLC
	SUBSTANTIALLY EQUIVALENT	1
RESORBABLE ORTHOPEDIC PRODUCTS, LLC
	SUBSTANTIALLY EQUIVALENT	1
SKELETAL KINETICS, LLC
	SUBSTANTIALLY EQUIVALENT	1
SYNTHES (USA) PRODUCTS LLC/NORIAN CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
SYNTHES USA PRODUCTS, LLC
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	30	152
Material Integrity Problem	19	19
Delivered as Unsterile Product	19	19
Biocompatibility	14	14
Loss of or Failure to Bond	11	11
Appropriate Term/Code Not Available	11	11
Failure To Adhere Or Bond	11	11
Device Markings/Labelling Problem	10	10
Migration or Expulsion of Device	5	5
Manufacturing, Packaging or Shipping Problem	5	5
Device Contaminated During Manufacture or Shipping	4	4
Material Fragmentation	4	4
Incomplete or Missing Packaging	3	3
Defective Device	3	247
Contamination /Decontamination Problem	3	3
Patient-Device Incompatibility	2	2
Component Missing	2	2
Device Operates Differently Than Expected	2	2
Other (for use when an appropriate device code cannot be identified)	2	2
Chemical Problem	1	1
Break	1	1
Insufficient Information	1	1
Unsealed Device Packaging	1	1
Device Packaging Compromised	1	1
Use of Device Problem	1	1
Material Deformation	1	1
Packaging Problem	1	1
Fluid/Blood Leak	1	1
Device Dislodged or Dislocated	1	1
Melted	1	1
Fungus in Device Environment	1	1
Improper or Incorrect Procedure or Method	1	1
Device Misassembled During Manufacturing /Shipping	1	1
Product Quality Problem	1	1
Material Protrusion/Extrusion	1	1
Device Contamination with Chemical or Other Material	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	44	44
Unspecified Infection	25	25
No Consequences Or Impact To Patient	21	21
No Known Impact Or Consequence To Patient	12	12
No Code Available	10	10
Inflammation	10	10
Insufficient Information	6	128
Not Applicable	5	5
Blood Loss	5	5
Hemorrhage/Bleeding	4	4
Cerebrospinal Fluid Leakage	3	247
Abscess	3	3
Erythema	3	3
Injury	3	3
Foreign Body Reaction	3	3
Surgical procedure	3	3
Hematoma	3	3
Hearing Impairment	3	3
Skin Inflammation/ Irritation	2	2
Migration	2	2
Paralysis	2	2
No Patient Involvement	2	2
Pain	2	2
Hypersensitivity/Allergic reaction	2	2
Fluid Discharge	2	2
Swelling/ Edema	2	2
Bacterial Infection	2	2
Implant Pain	1	1
Other (for use when an appropriate patient code cannot be identified)	1	1
Cyst(s)	1	1
Adhesion(s)	1	1
Post Operative Wound Infection	1	1
Ventricular Fibrillation	1	1
Memory Loss/Impairment	1	1
Visual Disturbances	1	1
Fever	1	1
Thrombosis	1	1
Radiation Exposure, Unintended	1	1
Decreased Sensitivity	1	1
Discomfort	1	1
Missing Value Reason	1	1
Patient Problem/Medical Problem	1	1
Impaired Healing	1	1
Headache	1	1
Tinnitus	1	1
Meningitis	1	1
Low Blood Pressure/ Hypotension	1	1
Fistula	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Baxter Healthcare Corporation	II	Jan-05-2024
2	Ethicon, Inc.	II	Mar-04-2009
3	Synthes USA HQ, Inc.	I	Aug-16-2012
4	Synthes, Inc.	II	Feb-11-2015