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	29	151
Material Integrity Problem	17	17
Delivered as Unsterile Product	17	17
Biocompatibility	14	14
Failure To Adhere Or Bond	11	11
Loss of or Failure to Bond	11	11
Appropriate Term/Code Not Available	11	11
Device Markings/Labelling Problem	10	10
Manufacturing, Packaging or Shipping Problem	5	5
Migration or Expulsion of Device	5	5
Material Fragmentation	4	4
Device Contaminated During Manufacture or Shipping	4	4
Incomplete or Missing Packaging	3	3
Defective Device	3	247
Contamination /Decontamination Problem	3	3
Device Operates Differently Than Expected	2	2
Patient-Device Incompatibility	2	2
Other (for use when an appropriate device code cannot be identified)	2	2
Component Missing	2	2
Melted	1	1
Fungus in Device Environment	1	1
Break	1	1
Fluid/Blood Leak	1	1
Unsealed Device Packaging	1	1
Product Quality Problem	1	1
Use of Device Problem	1	1
Improper or Incorrect Procedure or Method	1	1
Device Packaging Compromised	1	1
Device Dislodged or Dislocated	1	1
Device Contamination with Chemical or Other Material	1	1
Chemical Problem	1	1
Material Deformation	1	1
Device Misassembled During Manufacturing /Shipping	1	1
Material Protrusion/Extrusion	1	1
Packaging Problem	1	1
Insufficient Information	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	40	40
Unspecified Infection	24	24
No Consequences Or Impact To Patient	21	21
No Known Impact Or Consequence To Patient	12	12
Inflammation	10	10
No Code Available	10	10
Insufficient Information	6	128
Not Applicable	5	5
Blood Loss	5	5
Hemorrhage/Bleeding	4	4
Hearing Impairment	3	3
Hematoma	3	3
Abscess	3	3
Cerebrospinal Fluid Leakage	3	247
Erythema	3	3
Foreign Body Reaction	3	3
Injury	3	3
Surgical procedure	3	3
No Patient Involvement	2	2
Migration	2	2
Fluid Discharge	2	2
Hypersensitivity/Allergic reaction	2	2
Pain	2	2
Paralysis	2	2
Bacterial Infection	2	2
Swelling/ Edema	2	2
Skin Inflammation/ Irritation	2	2
Implant Pain	1	1
Missing Value Reason	1	1
Thrombosis	1	1
Tinnitus	1	1
Ventricular Fibrillation	1	1
Visual Disturbances	1	1
Low Blood Pressure/ Hypotension	1	1
Headache	1	1
Fever	1	1
Fistula	1	1
Cyst(s)	1	1
Adhesion(s)	1	1
Patient Problem/Medical Problem	1	1
Radiation Exposure, Unintended	1	1
Discomfort	1	1
Decreased Sensitivity	1	1
Impaired Healing	1	1
Meningitis	1	1
Post Operative Wound Infection	1	1
Memory Loss/Impairment	1	1
Other (for use when an appropriate patient code cannot be identified)	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