Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
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 Back to Search Results
Device pedicle screw spinal system, adolescent idiopathic scoliosis
Regulation Description Thoracolumbosacral pedicle screw system.
Definition Intended to stabilize the thoracolumbar spine as an adjunct to fusion using allograft and/or autograft to treat adolescent idiopathic scoliosis.
Product CodeOSH
Regulation Number 888.3070
Device Class 2

MDR Year MDR Reports MDR Events
2020 12 12
2021 2 2
2022 8 8
2023 19 19
2024 12 12

Device Problems MDRs with this Device Problem Events in those MDRs
Migration 13 13
Break 8 8
Material Twisted/Bent 7 7
Adverse Event Without Identified Device or Use Problem 7 7
Fracture 5 5
Device Slipped 3 3
Material Integrity Problem 3 3
Detachment of Device or Device Component 2 2
Naturally Worn 2 2
Loosening of Implant Not Related to Bone-Ingrowth 1 1
Insufficient Information 1 1
Device Dislodged or Dislocated 1 1
Therapeutic or Diagnostic Output Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 13 13
Insufficient Information 9 9
Failure of Implant 7 7
Pain 6 6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
No Known Impact Or Consequence To Patient 4 4
Implant Pain 4 4
Unspecified Infection 3 3
Osteolysis 2 2
No Consequences Or Impact To Patient 2 2
Joint Laxity 2 2
Nerve Damage 2 2
No Information 2 2
Spinal Column Injury 1 1
Bone Fracture(s) 1 1
Anxiety 1 1
Non-union Bone Fracture 1 1
Emotional Changes 1 1
Depression 1 1

-
-