TPLC - Total Product Life Cycle

show TPLC since

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

Premarket Reviews
Manufacturer	Decision
FIN-CERAMICA FAENZA S.P.A
	SUBSTANTIALLY EQUIVALENT	1
FIN-CERAMICA FAENZA SPA
	SUBSTANTIALLY EQUIVALENT	1
KONTOUR(XI’AN) MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
LONGEVITI NEURO SOLUTIONS, LLC
	SUBSTANTIALLY EQUIVALENT	6
MEDCAD
	SUBSTANTIALLY EQUIVALENT	1
METICULY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
OXFORD PERFORMANCE MATERIALS, INC.
	SUBSTANTIALLY EQUIVALENT	1
SYNTHES (USA) PRODUCTS LLC
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	142	142
Defective Device	53	53
Break	12	12
Insufficient Information	12	12
Appropriate Term/Code Not Available	11	11
Inadequacy of Device Shape and/or Size	9	9
Device Operates Differently Than Expected	6	6
Defective Component	6	6
Patient-Device Incompatibility	5	5
Fitting Problem	4	4
No Apparent Adverse Event	4	4
Loose or Intermittent Connection	4	4
Material Separation	4	4
Separation Problem	4	4
Patient Device Interaction Problem	3	3
Fracture	3	3
Manufacturing, Packaging or Shipping Problem	3	3
Difficult to Open or Remove Packaging Material	2	2
Device Markings/Labelling Problem	2	2
Use of Device Problem	2	2
Tear, Rip or Hole in Device Packaging	2	2
Crack	2	2
Product Quality Problem	2	2
Migration	2	2
Missing Information	1	1
Mechanical Problem	1	1
Melted	1	1
Microbial Contamination of Device	1	1
Incomplete or Missing Packaging	1	1
Device Issue	1	1
Decoupling	1	1
Difficult or Delayed Positioning	1	1
Disassembly	1	1
Material Fragmentation	1	1
Detachment Of Device Component	1	1
Contamination	1	1
Loss of Osseointegration	1	1
Detachment of Device or Device Component	1	1
Positioning Problem	1	1
Material Deformation	1	1
Material Integrity Problem	1	1
Device-Device Incompatibility	1	1
Difficult to Open or Close	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Unspecified Infection	101	101
No Code Available	55	55
No Clinical Signs, Symptoms or Conditions	46	46
No Known Impact Or Consequence To Patient	23	23
Failure of Implant	19	19
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	16	16
Injury	15	15
Impaired Healing	14	14
No Consequences Or Impact To Patient	11	11
Post Operative Wound Infection	10	10
Insufficient Information	7	7
Cerebrospinal Fluid Leakage	7	7
Wound Dehiscence	5	5
Pain	5	5
Non-union Bone Fracture	4	4
No Patient Involvement	4	4
Unspecified Tissue Injury	3	3
No Information	3	3
Hematoma	3	3
Bacterial Infection	2	2
Blurred Vision	2	2
Pocket Erosion	2	2
Swelling/ Edema	2	2
Tissue Breakdown	2	2
Patient Problem/Medical Problem	1	1
Numbness	1	1
Shaking/Tremors	1	1
Ambulation Difficulties	1	1
Cognitive Changes	1	1
Confusion/ Disorientation	1	1
Blood Loss	1	1
Weight Changes	1	1
Hydrocephalus	1	1
Drug Resistant Bacterial Infection	1	1
Seizures	1	1
Skin Erosion	1	1
Swelling	1	1
Tissue Damage	1	1
Inflammation	1	1
Memory Loss/Impairment	1	1
Nausea	1	1
Nerve Damage	1	1
Visual Impairment	1	1
Burning Sensation	1	1
Paralysis	1	1
Erosion	1	1
Abscess	1	1
Hemorrhage/Bleeding	1	1
Hemorrhage, Extradural	1	1
Intracranial Hemorrhage	1	1
Hypersensitivity/Allergic reaction	1	1
Edema	1	1
Eye Injury	1	1
Fall	1	1
Fatigue	1	1
Fever	1	1
Hair Loss	1	1
Headache	1	1