TPLC - Total Product Life Cycle

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

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	39	39
Device Appears to Trigger Rejection	6	6
Migration	5	5
Fracture	5	5
Break	3	3
Chemical Problem	1	1
Migration or Expulsion of Device	1	1
Crack	1	1
Material Disintegration	1	1
Insufficient Information	1	1
Improper Chemical Reaction	1	1
Loss of or Failure to Bond	1	1
Loss of Osseointegration	1	1
Temperature Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pain	18	18
No Code Available	17	17
Unspecified Infection	13	13
Inflammation	12	12
Post Operative Wound Infection	9	9
Swelling/ Edema	8	8
No Clinical Signs, Symptoms or Conditions	6	6
Cerebrospinal Fluid Leakage	4	4
Headache	4	4
Failure of Implant	3	3
Neurological Deficit/Dysfunction	3	3
Hearing Impairment	2	2
Wound Dehiscence	2	2
Inadequate Osseointegration	2	2
No Known Impact Or Consequence To Patient	2	2
Swelling	2	2
Visual Impairment	2	2
No Consequences Or Impact To Patient	2	2
Impaired Healing	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Nausea	1	1
Purulent Discharge	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