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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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New Search show TPLC since Back to Search Results
Device component, traction, invasive
Product CodeJEC
Regulation Number 888.3040
Device Class 2


Premarket Reviews
ManufacturerDecision
ANJON HOLDINGS LLC
  SUBSTANTIALLY EQUIVALENT 1
ANJON HOLDINGS, LLC
  SUBSTANTIALLY EQUIVALENT 1
ARBUTUS MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
HAND BIOMECHANICS LAB, INC.
  SUBSTANTIALLY EQUIVALENT 1
SINTEA BIOTECH, INC.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 1
SURGICAL INSTRUMENT SERVICE AND SAVINGS INC
  SUBSTANTIALLY EQUIVALENT 1
VIRAK ORTHOPEDIC RESEARCH, LLC
  SUBSTANTIALLY EQUIVALENT 1
VIRAK ORTHOPEDICS, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 6 6
2015 1 1
2016 8 8
2017 12 12
2018 2 2
2019 3 3
2020 6 6
2021 2 2
2022 3 3
2023 26 26
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Device-Device Incompatibility 27 27
Break 13 13
Unintended Movement 5 5
Adverse Event Without Identified Device or Use Problem 4 4
Detachment of Device or Device Component 4 4
Patient Device Interaction Problem 3 3
Mechanical Jam 3 3
Mechanical Problem 2 2
Migration or Expulsion of Device 2 2
Crack 2 2
Difficult to Advance 2 2
Positioning Problem 2 2
Difficult to Remove 2 2
Loose or Intermittent Connection 2 2
Device Slipped 1 1
Malposition of Device 1 1
Physical Resistance/Sticking 1 1
Patient-Device Incompatibility 1 1
Defective Component 1 1
Therapeutic or Diagnostic Output Failure 1 1
Contamination 1 1
Scratched Material 1 1
Material Fragmentation 1 1
Device Maintenance Issue 1 1
Material Too Rigid or Stiff 1 1
Component Missing 1 1
Material Twisted/Bent 1 1
Difficult To Position 1 1
No Apparent Adverse Event 1 1
Migration 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 31 31
No Code Available 11 11
No Known Impact Or Consequence To Patient 6 6
Failure of Implant 5 5
Injury 5 5
No Patient Involvement 3 3
Bacterial Infection 3 3
Insufficient Information 2 2
No Consequences Or Impact To Patient 2 2
Unspecified Infection 1 1
Death 1 1
No Information 1 1
Bone Fracture(s) 1 1
Burning Sensation 1 1
Numbness 1 1
Pain 1 1
Malunion of Bone 1 1
Unspecified Tissue Injury 1 1
Pseudoaneurysm 1 1
Internal Organ Perforation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Acumed LLC II Mar-16-2010
2 Anjon Holdings II Aug-10-2020
3 Hand Biomechanics Lab Inc II Oct-18-2016
4 Ossur Americas II Mar-11-2019
5 Stryker GmbH II Jan-07-2020
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