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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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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
ANJON HOLDINGS, LLC
  SUBSTANTIALLY EQUIVALENT 1
ARBUTUS MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
HAND BIOMECHANICS LAB, INC.
  SUBSTANTIALLY EQUIVALENT 1
VIRAK ORTHOPEDICS, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 12 12
2018 2 2
2019 3 3
2020 6 6
2021 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Break 7 7
Unintended Movement 5 5
Patient Device Interaction Problem 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Mechanical Jam 2 2
Therapeutic or Diagnostic Output Failure 1 1
Migration 1 1
Contamination 1 1
Loose or Intermittent Connection 1 1
Device Slipped 1 1
Defective Component 1 1
Malposition of Device 1 1
Patient-Device Incompatibility 1 1
Detachment of Device or Device Component 1 1
Material Twisted/Bent 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Injury 4 4
No Code Available 4 4
No Patient Involvement 3 3
Bacterial Infection 3 3
Failure of Implant 3 3
No Known Impact Or Consequence To Patient 2 2
No Consequences Or Impact To Patient 2 2
No Clinical Signs, Symptoms or Conditions 2 2
No Information 1 1
Malunion of Bone 1 1
Insufficient Information 1 1
Unspecified Infection 1 1
Internal Organ Perforation 1 1
Pain 1 1
Burning Sensation 1 1
Death 1 1
Numbness 1 1
Pseudoaneurysm 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Anjon Holdings II Aug-10-2020
2 Ossur Americas II Mar-11-2019
3 Stryker GmbH II Jan-07-2020
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