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
implant, fixation device, spinal
Product Code
JDN
Regulation Number
888.3060
Device Class
2
MDR Year
MDR Reports
MDR Events
2016
2
2
2017
6
6
2018
2
2
2019
6
6
2020
6
6
2021
2
2
2022
16
16
2023
8
8
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
9
9
Material Split, Cut or Torn
9
9
Material Separation
8
8
Adverse Event Without Identified Device or Use Problem
5
5
Appropriate Term/Code Not Available
2
2
Positioning Failure
2
2
Fracture
2
2
Mechanical Problem
2
2
Migration or Expulsion of Device
1
1
Improper or Incorrect Procedure or Method
1
1
Tear, Rip or Hole in Device Packaging
1
1
Patient-Device Incompatibility
1
1
Material Deformation
1
1
Material Integrity Problem
1
1
Therapeutic or Diagnostic Output Failure
1
1
Insufficient Information
1
1
Crack
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
18
18
Failure of Implant
6
6
Pain
5
5
Implant Pain
4
4
Patient Problem/Medical Problem
3
3
No Code Available
3
3
Unspecified Infection
3
3
Laceration(s)
1
1
Abscess
1
1
Dysphagia/ Odynophagia
1
1
Fall
1
1
Swelling
1
1
Tissue Damage
1
1
Non-union Bone Fracture
1
1
Impaired Healing
1
1
No Patient Involvement
1
1
No Known Impact Or Consequence To Patient
1
1
Insufficient Information
1
1
-
-