TPLC - Total Product Life Cycle

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Device	material, polytetrafluoroethylene vitreous carbon, for maxillofacial reconstruction
Regulation Description	Polytetrafluoroethylene with carbon fibers composite implant material.
Product Code	KKY
Regulation Number	878.3500
Device Class	2

Premarket Reviews
Manufacturer	Decision
LONGEVITI NEURO SOLUTIONS, LLC
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	16	16
Inadequacy of Device Shape and/or Size	5	5
Insufficient Information	2	2
Labelling, Instructions for Use or Training Problem	2	2
Expulsion	1	1
Break	1	1
Off-Label Use	1	1
Crack	1	1
Patient-Device Incompatibility	1	1
Patient Device Interaction Problem	1	1
Fracture	1	1
Appropriate Term/Code Not Available	1	1
Device Appears to Trigger Rejection	1	1
Loose or Intermittent Connection	1	1
Improper or Incorrect Procedure or Method	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	6	6
No Clinical Signs, Symptoms or Conditions	4	4
Unspecified Infection	3	3
Insufficient Information	3	3
Necrosis	2	2
No Information	2	2
Pain	2	2
Erosion	2	2
Impaired Healing	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Wound Dehiscence	1	1
Infection, Pyrogenic	1	1
Skin Inflammation/ Irritation	1	1
Post Operative Wound Infection	1	1
Skin Erosion	1	1
Injury	1	1
Discomfort	1	1
Depression	1	1
Fluid Discharge	1	1
Swelling/ Edema	1	1
Cerebrospinal Fluid Leakage	1	1
Hemorrhage/Bleeding	1	1
Pocket Erosion	1	1
Bruise/Contusion	1	1