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TPLC
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show TPLC since
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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
SYNTHES (USA) PRODUCTS LLC
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
54
54
2020
63
63
2021
63
63
2022
57
57
2023
32
32
2024
10
10
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
143
143
Defective Device
57
57
Insufficient Information
13
13
Break
11
11
Appropriate Term/Code Not Available
11
11
Inadequacy of Device Shape and/or Size
7
7
Defective Component
6
6
No Apparent Adverse Event
5
5
Material Separation
4
4
Separation Problem
4
4
Manufacturing, Packaging or Shipping Problem
3
3
Device Markings/Labelling Problem
2
2
Crack
2
2
Difficult to Open or Remove Packaging Material
2
2
Patient Device Interaction Problem
2
2
Tear, Rip or Hole in Device Packaging
2
2
Product Quality Problem
2
2
Migration
2
2
Material Integrity Problem
1
1
Decoupling
1
1
Missing Information
1
1
Fracture
1
1
Difficult to Open or Close
1
1
Use of Device Problem
1
1
Melted
1
1
Difficult or Delayed Positioning
1
1
Material Fragmentation
1
1
Incomplete or Missing Packaging
1
1
Fitting Problem
1
1
Device-Device Incompatibility
1
1
Loss of Osseointegration
1
1
Microbial Contamination of Device
1
1
Detachment of Device or Device Component
1
1
Positioning Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Unspecified Infection
108
108
No Clinical Signs, Symptoms or Conditions
53
53
No Code Available
41
41
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
16
16
Injury
14
14
No Known Impact Or Consequence To Patient
14
14
Failure of Implant
12
12
Insufficient Information
11
11
Post Operative Wound Infection
10
10
Impaired Healing
6
6
No Consequences Or Impact To Patient
6
6
Wound Dehiscence
6
6
Cerebrospinal Fluid Leakage
5
5
Non-union Bone Fracture
4
4
No Patient Involvement
4
4
Pain
3
3
Hematoma
3
3
Unspecified Tissue Injury
3
3
Swelling/ Edema
2
2
Bacterial Infection
2
2
No Information
2
2
Pocket Erosion
2
2
Seizures
1
1
Skin Erosion
1
1
Swelling
1
1
Tissue Damage
1
1
Blurred Vision
1
1
Visual Impairment
1
1
Tissue Breakdown
1
1
Numbness
1
1
Cognitive Changes
1
1
Erosion
1
1
Abscess
1
1
Edema
1
1
Fall
1
1
Hair Loss
1
1
Hemorrhage/Bleeding
1
1
Hemorrhage, Extradural
1
1
Intracranial Hemorrhage
1
1
Hypersensitivity/Allergic reaction
1
1
Paralysis
1
1
Inflammation
1
1
Nerve Damage
1
1
Hydrocephalus
1
1
Skin Infection
1
1
Drug Resistant Bacterial Infection
1
1
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