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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
Product CodeJEC
Regulation Number 888.3040
Device Class 2


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

MDR Year MDR Reports MDR Events
2019 3 3
2020 6 6
2021 2 2
2022 3 3
2023 26 26

Device Problems MDRs with this Device Problem Events in those MDRs
Device-Device Incompatibility 25 25
Detachment of Device or Device Component 3 3
Break 3 3
Mechanical Jam 2 2
Adverse Event Without Identified Device or Use Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Unintended Movement 1 1
Patient Device Interaction Problem 1 1
Migration 1 1
Physical Resistance/Sticking 1 1
Loose or Intermittent Connection 1 1
Mechanical Problem 1 1
Device Slipped 1 1
Defective Component 1 1
Material Twisted/Bent 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 30 30
Failure of Implant 2 2
No Consequences Or Impact To Patient 2 2
Injury 2 2
No Known Impact Or Consequence To Patient 2 2
No Information 1 1
Malunion of Bone 1 1
Unspecified Tissue Injury 1 1
Insufficient Information 1 1
Bacterial Infection 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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