TPLC - Total Product Life Cycle

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Device	methyl methacrylate for cranioplasty
Product Code	GXP
Regulation Number	882.5300
Device Class	2

Premarket Reviews
Manufacturer	Decision
DIMENSIONAL BIOCERAMICS, LLC
	SUBSTANTIALLY EQUIVALENT	1
ORTHOCON, INC.
	SUBSTANTIALLY EQUIVALENT	4

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	44	44
Fracture	6	6
Migration	4	4
Break	3	3
Device Appears to Trigger Rejection	2	2
Defective Component	1	1
Loss of Osseointegration	1	1
Chemical Problem	1	1
Improper Chemical Reaction	1	1
Crack	1	1
Material Disintegration	1	1
Migration or Expulsion of Device	1	1
Loss of or Failure to Bond	1	1
Temperature Problem	1	1
Insufficient Information	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Code Available	18	18
Pain	17	17
Unspecified Infection	15	15
Inflammation	12	12
Post Operative Wound Infection	9	9
No Clinical Signs, Symptoms or Conditions	6	6
Cerebrospinal Fluid Leakage	6	6
No Known Impact Or Consequence To Patient	4	4
Swelling/ Edema	4	4
Headache	4	4
Impaired Healing	3	3
Failure of Implant	3	3
Neurological Deficit/Dysfunction	3	3
No Consequences Or Impact To Patient	3	3
Hearing Impairment	2	2
Wound Dehiscence	2	2
Inadequate Osseointegration	2	2
Swelling	2	2
Visual Impairment	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Nausea	1	1
Post Traumatic Wound Infection	1	1
Weakness	1	1
Foreign Body In Patient	1	1
Vomiting	1	1
Insufficient Information	1	1
Facial Nerve Paralysis	1	1
Pocket Erosion	1	1
Device Embedded In Tissue or Plaque	1	1