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
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
Back to Search Results
Device
awl
Product Code
HWJ
Regulation Number
888.4540
Device Class
1
MDR Year
MDR Reports
MDR Events
2019
17
17
2020
9
9
2021
9
9
2022
10
10
2023
9
9
2024
1
1
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
26
26
Adverse Event Without Identified Device or Use Problem
9
9
Failure to Cut
7
7
Material Deformation
6
6
Contamination /Decontamination Problem
3
3
Entrapment of Device
3
3
Material Twisted/Bent
3
3
Dull, Blunt
2
2
Fracture
2
2
Delivered as Unsterile Product
1
1
Device Damaged Prior to Use
1
1
Material Integrity Problem
1
1
Scratched Material
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
23
23
No Code Available
12
12
No Consequences Or Impact To Patient
8
8
Foreign Body In Patient
4
4
Insufficient Information
4
4
Injury
2
2
No Patient Involvement
2
2
Decreased Sensitivity
1
1
Hypoesthesia
1
1
Fatigue
1
1
Nerve Damage
1
1
Paresis
1
1
Weakness
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Device Embedded In Tissue or Plaque
1
1
Unspecified Tissue Injury
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Alphatec Spine, Inc.
II
Aug-28-2023
2
K2M, Inc
II
Apr-24-2020
-
-