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 posterior ratcheting rod system
Definition Stabilization or correction of adolescent idiopathic scoliosis without the use of fusion.
Product CodeQGP
Device Class Not Classified

MDR Year MDR Reports MDR Events
2020 21 21
2021 47 47
2022 68 68
2023 70 70
2024 21 21

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 50 50
Break 39 39
No Apparent Adverse Event 24 24
Fracture 23 23
Unintended Movement 21 21
Migration 17 17
Improper or Incorrect Procedure or Method 15 15
Appropriate Term/Code Not Available 14 14
Noise, Audible 13 13
Off-Label Use 8 8
Patient-Device Incompatibility 7 7
Insufficient Information 4 4
Mechanical Problem 4 4
Loss of Osseointegration 3 3
Device Dislodged or Dislocated 3 3
Detachment of Device or Device Component 2 2
Failure to Align 2 2
Use of Device Problem 2 2
Inaccurate Information 2 2
Loosening of Implant Not Related to Bone-Ingrowth 1 1
Degraded 1 1
Biocompatibility 1 1
Overcorrection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 70 70
Failure of Implant 61 61
Pain 28 28
Implant Pain 20 20
Physical Asymmetry 15 15
Insufficient Information 15 15
Unspecified Infection 8 8
Therapeutic Response, Decreased 6 6
Discomfort 5 5
Bacterial Infection 4 4
Post Operative Wound Infection 4 4
Wound Dehiscence 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Unspecified Tissue Injury 2 2
Osteolysis 2 2
Cerebrospinal Fluid Leakage 1 1
Fistula 1 1
Paresthesia 1 1
Metal Related Pathology 1 1

-
-