• 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 component, traction, invasive
Regulation Description Smooth or threaded metallic bone fixation fastener.
Product CodeJEC
Regulation Number 888.3040
Device Class 2


Premarket Reviews
ManufacturerDecision
ANJON HOLDINGS LLC
  SUBSTANTIALLY EQUIVALENT 1
ARBUTUS MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 6 6
2021 2 2
2022 3 3
2023 26 26
2024 2 2
2025 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Device-Device Incompatibility 28 28
Break 5 5
Mechanical Jam 2 2
Detachment of Device or Device Component 2 2
Crack 2 2
Unintended Movement 1 1
Scratched Material 1 1
Material Twisted/Bent 1 1
Mechanical Problem 1 1
Migration 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Defective Component 1 1
Device Slipped 1 1
Physical Resistance/Sticking 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 32 32
Failure of Implant 2 2
Insufficient Information 2 2
Injury 2 2
No Consequences Or Impact To Patient 1 1
No Information 1 1
Unspecified Tissue Injury 1 1
Malunion of Bone 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Anjon Holdings II Aug-10-2020
2 Stryker GmbH II Jan-07-2020
-
-