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	16	16
Device Appears to Trigger Rejection	6	6
Migration	4	4
Fracture	3	3
Migration or Expulsion of Device	1	1
Temperature Problem	1	2
Insufficient Information	1	1
Loss of Osseointegration	1	1
Chemical Problem	1	1
Improper Chemical Reaction	1	2
Loss of or Failure to Bond	1	1
Break	1	1
Crack	1	1
Material Disintegration	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pain	8	8
Swelling/ Edema	8	8
No Clinical Signs, Symptoms or Conditions	6	7
Inflammation	5	5
Failure of Implant	3	3
Post Operative Wound Infection	3	3
Unspecified Infection	2	2
Inadequate Osseointegration	2	2
Cerebrospinal Fluid Leakage	2	2
Convulsion/Seizure	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Purulent Discharge	1	1
Post Traumatic Wound Infection	1	1
Insufficient Information	1	1
Pocket Erosion	1	1
Device Embedded In Tissue or Plaque	1	1