TPLC - Total Product Life Cycle

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Device	plate, cranioplasty, preformed, non-alterable
Regulation Description	Preformed nonalterable cranioplasty plate.
Product Code	GXN
Regulation Number	882.5330
Device Class	2

Premarket Reviews
Manufacturer	Decision
CG BIO CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
FIN-CERAMICA FAENZA S.P.A.
	SUBSTANTIALLY EQUIVALENT	1
KLS-MARTIN L.P.
	SUBSTANTIALLY EQUIVALENT	1
KONTOUR(XI’AN) MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
LONGEVITI NEURO SOLUTIONS
	SUBSTANTIALLY EQUIVALENT	1
LONGEVITI NEURO SOLUTIONS, LLC
	SUBSTANTIALLY EQUIVALENT	3
MEDCAD
	SUBSTANTIALLY EQUIVALENT	1
METICULY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
SYNTHES GMBH
	SUBSTANTIALLY EQUIVALENT	1
THE SURGEON GENERAL, DEPARTMENT OF THE ARMY (TSG-DA)
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	123	123
Defective Device	44	44
Break	8	8
Insufficient Device Problem Information	7	7
Inadequacy of Device Shape and/or Size	3	3
Migration	3	4
Appropriate Device Problem Term/Code Not Available	3	3
Difficult or Delayed Positioning	3	3
No Apparent Adverse Event	2	2
Difficult to Open or Remove Packaging Material	2	2
Tear, Rip or Hole in Device Packaging	2	2
Product Quality Problem	1	1
Material Erosion	1	2
Device-Device Incompatibility	1	1
Defective Component	1	1
Nonstandard Device	1	1
Difficult to Open or Close	1	1
Failure to Clean Adequately	1	1
Positioning Failure	1	1
Prophylactic removal due to corrective action	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Fracture	1	1
Loss of Osseointegration	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Unspecified Infection	86	86
No Clinical Signs, Symptoms or Conditions	56	56
Insufficient Information	24	24
Post Operative Wound Infection	17	17
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	15	15
Unspecified Tissue Injury	4	4
Cerebrospinal Fluid Leakage	4	4
Hematoma	4	4
Failure of Implant	3	3
Pain	3	4
Nonunion/Delayed-union Bone Fracture	3	3
Tissue Breakdown	2	2
Wound Dehiscence	2	2
Impaired Healing	2	2
Swelling/ Edema	2	2
Wound Infection	2	2
Unspecified Mental, Emotional or Behavioural Problem	2	2
Hydrocephalus	1	1
Skin Tears	1	1
Hair Loss	1	1
Paralysis	1	1
Skin Infection	1	1
Medical device site infection	1	1
Eye Pain	1	2
Metal Related Pathology	1	2
Dry Mouth	1	2
High metal ion levels	1	2
Drug Resistant Bacterial Infection	1	1
Nerve Damage	1	1
Bacterial Infection	1	1
Abscess	1	1
Fall	1	1
Numbness	1	1
Hemolysis	1	1
Cognitive Changes	1	1
Blurred Vision	1	1