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 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	7
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	174	174
Defective Device	64	64
Insufficient Information	15	15
Appropriate Term/Code Not Available	12	12
Break	11	11
Inadequacy of Device Shape and/or Size	10	10
Device Operates Differently Than Expected	6	6
Defective Component	6	6
No Apparent Adverse Event	5	5
Patient-Device Incompatibility	5	5
Fitting Problem	4	4
Loose or Intermittent Connection	4	4
Separation Problem	4	4
Fracture	4	4
Migration	4	4
Material Separation	4	4
Manufacturing, Packaging or Shipping Problem	3	3
Patient Device Interaction Problem	3	3
Tear, Rip or Hole in Device Packaging	2	2
Product Quality Problem	2	2
Use of Device Problem	2	2
Device Markings/Labelling Problem	2	2
Crack	2	2
Difficult to Open or Remove Packaging Material	2	2
Material Fragmentation	1	1
Microbial Contamination of Device	1	1
Contamination	1	1
Difficult or Delayed Positioning	1	1
Material Deformation	1	1
Decoupling	1	1
Positioning Problem	1	1
Material Integrity Problem	1	1
Disassembly	1	1
Material Erosion	1	1
Detachment of Device or Device Component	1	1
Missing Information	1	1
Incomplete or Missing Packaging	1	1
Mechanical Problem	1	1
Melted	1	1
Difficult to Open or Close	1	1
Device-Device Incompatibility	1	1
Device Issue	1	1
Detachment Of Device Component	1	1
Loss of Osseointegration	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Unspecified Infection	131	131
No Code Available	55	55
No Clinical Signs, Symptoms or Conditions	54	54
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
Insufficient Information	15	15
Impaired Healing	14	14
Post Operative Wound Infection	12	12
No Consequences Or Impact To Patient	11	11
Cerebrospinal Fluid Leakage	7	7
Wound Dehiscence	6	6
Pain	6	6
Unspecified Tissue Injury	4	4
Non-union Bone Fracture	4	4
No Patient Involvement	4	4
Tissue Breakdown	3	3
No Information	3	3
Hematoma	3	3
Pocket Erosion	2	2
Bacterial Infection	2	2
Blurred Vision	2	2
Swelling/ Edema	2	2
Ambulation Difficulties	1	1
Eye Pain	1	1
Hemorrhage/Bleeding	1	1
Headache	1	1
Erosion	1	1
Tissue Damage	1	1
Shaking/Tremors	1	1
Hydrocephalus	1	1
Eye Injury	1	1
Abscess	1	1
Visual Impairment	1	1
Hair Loss	1	1
Fall	1	1
Numbness	1	1
Swelling	1	1
Nerve Damage	1	1
Burning Sensation	1	1
Skin Erosion	1	1
Paralysis	1	1
Intracranial Hemorrhage	1	1
Fever	1	1
Confusion/ Disorientation	1	1
Blood Loss	1	1
Cognitive Changes	1	1
Edema	1	1
Inflammation	1	1