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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
AESCULAP, INC.
SUBSTANTIALLY EQUIVALENT
1
BIOARCHITECTS USA, LLC
SUBSTANTIALLY EQUIVALENT
1
FIN-CERAMICA FAENZA S.P.A
SUBSTANTIALLY EQUIVALENT
1
FIN-CERAMICA FAENZA S.P.A.
SUBSTANTIALLY EQUIVALENT
1
FIN-CERAMICA FAENZA SPA
SUBSTANTIALLY EQUIVALENT
3
JEIL MEDICAL CORPORATION
SUBSTANTIALLY EQUIVALENT
1
KELYNIAM GLOBAL, INC
SUBSTANTIALLY EQUIVALENT
1
KELYNIAM GLOBAL, INC.
SUBSTANTIALLY EQUIVALENT
1
KLS MARTIN L.P.
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
OSSDSIGN AB
SUBSTANTIALLY EQUIVALENT
1
OSTEOSYMBIONICS, LLC
SUBSTANTIALLY EQUIVALENT
2
OXFORD PERFORMANCE MATERIALS
SUBSTANTIALLY EQUIVALENT
1
OXFORD PERFORMANCE MATERIALS, INC.
SUBSTANTIALLY EQUIVALENT
1
SYNTHES (USA) PRODUCTS LLC
SUBSTANTIALLY EQUIVALENT
1
VANDUZEN DBA MEDCAD
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
60
60
2015
47
47
2016
33
33
2017
74
74
2018
56
56
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
239
239
Defective Device
60
60
Inadequacy of Device Shape and/or Size
36
36
Insufficient Information
34
34
Device Operates Differently Than Expected
22
22
Break
21
21
Fitting Problem
18
18
Unintended Movement
17
17
Appropriate Term/Code Not Available
17
17
Patient-Device Incompatibility
8
8
Loose or Intermittent Connection
8
8
Fracture
6
6
Failure To Adhere Or Bond
6
6
Defective Component
6
6
Use of Device Problem
6
6
No Apparent Adverse Event
5
5
Material Deformation
5
5
Material Separation
4
4
Separation Problem
4
4
Disassembly
4
4
Improper or Incorrect Procedure or Method
3
3
Material Integrity Problem
3
3
Contamination
3
3
Device Inoperable
3
3
Difficult To Position
3
3
Manufacturing, Packaging or Shipping Problem
3
3
Patient Device Interaction Problem
3
3
Detachment Of Device Component
2
2
Positioning Problem
2
2
Device Markings/Labelling Problem
2
2
Material Distortion
2
2
Crack
2
2
Difficult to Open or Remove Packaging Material
2
2
Migration
2
2
Tear, Rip or Hole in Device Packaging
2
2
Product Quality Problem
2
2
Decoupling
1
1
Compatibility Problem
1
1
Missing Information
1
1
Migration or Expulsion of Device
1
1
Device Operational Issue
1
1
Difficult to Open or Close
1
1
Shipping Damage or Problem
1
1
Melted
1
1
Difficult or Delayed Positioning
1
1
Microbial Contamination of Device
1
1
Detachment of Device or Device Component
1
1
Mechanical Problem
1
1
Component Falling
1
1
Material Erosion
1
1
Difficult to Insert
1
1
Malposition of Device
1
1
Device-Device Incompatibility
1
1
Incorrect Device Or Component Shipped
1
1
Loss of Osseointegration
1
1
Human Factors Issue
1
1
Device Issue
1
1
Material Fragmentation
1
1
Incomplete or Missing Packaging
1
1
Device Handling Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Unspecified Infection
190
190
No Code Available
98
98
No Known Impact Or Consequence To Patient
97
97
No Clinical Signs, Symptoms or Conditions
53
53
Failure of Implant
22
22
Impaired Healing
19
19
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
16
16
Injury
15
15
No Consequences Or Impact To Patient
14
14
Post Operative Wound Infection
14
14
Pain
14
14
Insufficient Information
11
11
No Information
10
10
Sedation
10
10
Cerebrospinal Fluid Leakage
10
10
Wound Dehiscence
7
7
Bacterial Infection
7
7
Non-union Bone Fracture
4
4
No Patient Involvement
4
4
Reaction
4
4
Unspecified Tissue Injury
3
3
Hematoma
3
3
Hemorrhage/Bleeding
3
3
Emotional Changes
3
3
Abscess
2
2
Necrosis
2
2
Inflammation
2
2
Paralysis
2
2
Pocket Erosion
2
2
Seroma
2
2
Swelling
2
2
Swelling/ Edema
2
2
Hydrocephalus
2
2
Tissue Breakdown
2
2
Fluid Discharge
2
2
Blurred Vision
2
2
Visual Impairment
1
1
Burning Sensation
1
1
Discharge
1
1
Meningitis
1
1
Foreign Body In Patient
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
Skin Infection
1
1
Drug Resistant Bacterial Infection
1
1
Numbness
1
1
Tissue Damage
1
1
Skin Erosion
1
1
Staphylococcus Aureus
1
1
Seizures
1
1
Laceration(s)
1
1
Memory Loss/Impairment
1
1
Nausea
1
1
Nerve Damage
1
1
Death
1
1
Edema
1
1
Adhesion(s)
1
1
Erosion
1
1
Hemorrhage, Extradural
1
1
Intracranial Hemorrhage
1
1
Hypersensitivity/Allergic reaction
1
1
Eye Injury
1
1
Fall
1
1
Fatigue
1
1
Fever
1
1
Fistula
1
1
Foreign Body Reaction
1
1
Hair Loss
1
1
Headache
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Kelyniam Global, Inc.
II
May-14-2018
2
Synthes (USA) Products LLC
II
Sep-23-2015
3
Zimmer Biomet, Inc.
II
Nov-06-2018
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