Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
510(k)
|
DeNovo
|
Registration & Listing
|
Adverse Events
|
Recalls
|
PMA
|
HDE
|
Classification
|
Standards
CFR Title 21
|
Radiation-Emitting Products
|
X-Ray Assembler
|
Medsun Reports
|
CLIA
|
TPLC
New Search
show TPLC since
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
Back to Search Results
Device
cover, burr hole
Regulation Description
Burr hole cover.
Product Code
GXR
Regulation Number
882.5250
Device Class
2
Premarket Reviews
Manufacturer
Decision
CHENDU MEDART MEDICAL SCIENTIFIC CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
NEOS SURGERY S.L
SUBSTANTIALLY EQUIVALENT
1
NEUROVENTION LLC
SUBSTANTIALLY EQUIVALENT
1
OSSAWARE BIOTECH CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2020
16
16
2021
28
28
2022
13
13
2023
11
11
2024
3
3
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
16
16
Break
11
11
Difficult to Open or Close
7
7
Device Appears to Trigger Rejection
6
6
Insufficient Information
6
6
Human-Device Interface Problem
4
4
Unstable
4
4
Patient Device Interaction Problem
4
4
Unintended Movement
4
4
Mechanics Altered
2
2
Fracture
2
2
Nonstandard Device
2
2
Product Quality Problem
2
2
Compatibility Problem
2
2
Positioning Problem
1
1
Failure to Form Staple
1
1
Activation, Positioning or Separation Problem
1
1
Improper or Incorrect Procedure or Method
1
1
Shipping Damage or Problem
1
1
Loosening of Implant Not Related to Bone-Ingrowth
1
1
Detachment of Device or Device Component
1
1
Patient-Device Incompatibility
1
1
Mechanical Problem
1
1
Appropriate Term/Code Not Available
1
1
Output Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
43
43
Hematoma
4
4
Visual Impairment
3
3
Post Operative Wound Infection
2
2
Fluid Discharge
2
2
Patient Problem/Medical Problem
2
2
No Known Impact Or Consequence To Patient
2
2
Unspecified Infection
2
2
Inflammation
2
2
Skin Inflammation/ Irritation
2
2
Swelling/ Edema
2
2
Insufficient Information
2
2
Impaired Healing
1
1
Swelling
1
1
No Consequences Or Impact To Patient
1
1
Wound Dehiscence
1
1
Erosion
1
1
Fall
1
1
Granuloma
1
1
Hyperplasia
1
1
Hypersensitivity/Allergic reaction
1
1
Failure of Implant
1
1
Nodule
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Medtronic Neuromodulation
II
Aug-06-2021
-
-