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TPLC
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show TPLC since
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Device
methyl methacrylate for cranioplasty
Product Code
GXP
Regulation Number
882.5300
Device Class
2
Premarket Reviews
Manufacturer
Decision
DIMENSIONAL BIOCERAMICS, LLC
SUBSTANTIALLY EQUIVALENT
1
DOCTORS RESEARCH GROUP, INC.
SE - WITH LIMITATIONS
1
ORTHOCON, INC.
SUBSTANTIALLY EQUIVALENT
3
SKELETAL KINETICS, LLC.
SUBSTANTIALLY EQUIVALENT
1
STRYKER
SUBSTANTIALLY EQUIVALENT
1
SYNTHES USA PRODUCTS LLC
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
19
19
2015
13
13
2016
17
17
2017
16
16
2018
9
9
2019
9
9
2020
31
31
2021
14
14
2022
3
3
2023
2
2
2024
4
4
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
61
61
Insufficient Information
14
14
Device Operates Differently Than Expected
9
9
Fracture
8
8
Break
6
6
Crack
4
4
Migration
4
4
Migration or Expulsion of Device
4
4
Failure To Adhere Or Bond
3
3
Device Contamination with Chemical or Other Material
3
3
Loss of or Failure to Bond
3
3
Device Operational Issue
3
3
Device Appears to Trigger Rejection
2
2
Fluid/Blood Leak
2
2
Material Integrity Problem
2
2
Defective Component
2
2
Device Expiration Issue
2
2
Fitting Problem
1
1
Compatibility Problem
1
1
Chemical Problem
1
1
Material Erosion
1
1
Material Disintegration
1
1
Contamination
1
1
Microbial Contamination of Device
1
1
Material Fragmentation
1
1
Detachment of Device or Device Component
1
1
Device Disinfection Or Sterilization Issue
1
1
Device Packaging Compromised
1
1
Difficult or Delayed Activation
1
1
Appropriate Term/Code Not Available
1
1
Coagulation in Device or Device Ingredient
1
1
Improper Chemical Reaction
1
1
Temperature Problem
1
1
Loss of Osseointegration
1
1
Detachment Of Device Component
1
1
Component Falling
1
1
Output Problem
1
1
Positioning Problem
1
1
Defective Device
1
1
Improper or Incorrect Procedure or Method
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
28
28
Unspecified Infection
22
22
No Code Available
21
21
Pain
21
21
Post Operative Wound Infection
16
16
Inflammation
14
14
Cerebrospinal Fluid Leakage
10
10
Impaired Healing
8
8
No Information
7
7
No Clinical Signs, Symptoms or Conditions
6
6
No Consequences Or Impact To Patient
5
5
Headache
5
5
Failure of Implant
5
5
Swelling/ Edema
4
4
Wound Dehiscence
3
3
Neurological Deficit/Dysfunction
3
3
Skin Inflammation
3
3
Swelling
3
3
Device Embedded In Tissue or Plaque
2
2
Pulmonary Embolism
2
2
Meningitis
2
2
Reaction
2
2
Visual Impairment
2
2
Disseminated Intravascular Coagulation (DIC)
2
2
Cardiopulmonary Arrest
2
2
Foreign Body In Patient
2
2
Staphylococcus Aureus
2
2
Dizziness
2
2
Inadequate Osseointegration
2
2
Death
2
2
Hearing Impairment
2
2
Vomiting
1
1
Numbness
1
1
Burning Sensation
1
1
Insufficient Information
1
1
Weakness
1
1
Post Traumatic Wound Infection
1
1
Autoimmune Disorder
1
1
Abscess
1
1
Nausea
1
1
Soreness
1
1
Tissue Damage
1
1
Facial Nerve Paralysis
1
1
Hearing Loss
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Pocket Erosion
1
1
Neuropathy
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Doctor's Research Group, Inc.
II
May-08-2012
2
OSTEOPORE INTERNATIONAL PTE LTD
II
Jan-11-2012
3
Skeletal Kinetics, Llc
II
Jan-15-2021
4
Skeletal Kinetics, Llc
II
Jul-15-2020
5
Skeletal Kinetics, Llc
II
May-20-2020
6
Stryker Craniomaxillofacial Division
II
Aug-26-2013
7
Stryker Leibinger GmbH & Co. KG
II
Apr-19-2021
8
Synthes USA (HQ), Inc.
II
Nov-16-2009
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