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	2
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
OSSDSIGN AB
	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	194	194
Defective Device	61	61
Insufficient Information	17	17
Unintended Movement	16	16
Inadequacy of Device Shape and/or Size	16	16
Break	13	13
Appropriate Term/Code Not Available	13	13
Device Operates Differently Than Expected	9	9
Patient-Device Incompatibility	8	8
Fitting Problem	6	6
Defective Component	6	6
Loose or Intermittent Connection	6	6
Fracture	5	5
No Apparent Adverse Event	5	5
Separation Problem	4	4
Material Separation	4	4
Disassembly	3	3
Contamination	3	3
Use of Device Problem	3	3
Manufacturing, Packaging or Shipping Problem	3	3
Patient Device Interaction Problem	3	3
Migration	2	2
Difficult to Open or Remove Packaging Material	2	2
Material Deformation	2	2
Device Markings/Labelling Problem	2	2
Tear, Rip or Hole in Device Packaging	2	2
Crack	2	2
Product Quality Problem	2	2
Device Inoperable	2	2
Material Fragmentation	1	1
Difficult to Insert	1	1
Mechanical Problem	1	1
Melted	1	1
Decoupling	1	1
Difficult or Delayed Positioning	1	1
Failure To Adhere Or Bond	1	1
Detachment Of Device Component	1	1
Loss of Osseointegration	1	1
Detachment of Device or Device Component	1	1
Microbial Contamination of Device	1	1
Incomplete or Missing Packaging	1	1
Device Issue	1	1
Device-Device Incompatibility	1	1
Difficult to Open or Close	1	1
Material Distortion	1	1
Material Integrity Problem	1	1
Human Factors Issue	1	1
Incorrect Device Or Component Shipped	1	1
Positioning Problem	1	1
Device Handling Problem	1	1
Missing Information	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Unspecified Infection	148	148
No Code Available	73	73
No Clinical Signs, Symptoms or Conditions	53	53
No Known Impact Or Consequence To Patient	52	52
Failure of Implant	21	21
Impaired Healing	17	17
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	16	16
Injury	15	15
No Consequences Or Impact To Patient	13	13
Post Operative Wound Infection	12	12
Insufficient Information	11	11
Cerebrospinal Fluid Leakage	9	9
Wound Dehiscence	7	7
Pain	5	5
Non-union Bone Fracture	4	4
Unspecified Tissue Injury	4	4
No Patient Involvement	4	4
No Information	3	3
Bacterial Infection	3	3
Hematoma	3	3
Pocket Erosion	2	2
Blurred Vision	2	2
Seroma	2	2
Swelling/ Edema	2	2
Tissue Breakdown	2	2
Sedation	2	2
Hydrocephalus	2	2
Skin Infection	1	1
Drug Resistant Bacterial Infection	1	1
Patient Problem/Medical Problem	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
Meningitis	1	1
Reaction	1	1
Numbness	1	1
Skin Erosion	1	1
Swelling	1	1
Tissue Damage	1	1
Visual Impairment	1	1
Burning Sensation	1	1
Staphylococcus Aureus	1	1
Seizures	1	1
Paralysis	1	1
Inflammation	1	1
Memory Loss/Impairment	1	1
Nausea	1	1
Necrosis	1	1
Nerve Damage	1	1
Hemorrhage/Bleeding	1	1
Hemorrhage, Extradural	1	1
Intracranial Hemorrhage	1	1
Hypersensitivity/Allergic reaction	1	1
Erosion	1	1
Abscess	1	1
Edema	1	1
Eye Injury	1	1
Fall	1	1
Fatigue	1	1
Fever	1	1
Foreign Body Reaction	1	1
Hair Loss	1	1
Headache	1	1