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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device component, traction, non-invasive
Product CodeKQZ
Regulation Number 888.5890
Device Class 1

MDR Year MDR Reports MDR Events
2015 1 1
2016 3 3
2017 2 2
2019 6 6
2020 7 7
2021 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 6 6
Manufacturing, Packaging or Shipping Problem 4 4
Positioning Failure 2 2
Mechanical Problem 2 2
Delivered as Unsterile Product 1 1
Material Too Rigid or Stiff 1 1
Inadequate or Insufficient Training 1 1
Patient-Device Incompatibility 1 1
Electromagnetic Interference 1 1
Adverse Event Without Identified Device or Use Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 5 5
No Clinical Signs, Symptoms or Conditions 5 5
No Known Impact Or Consequence To Patient 4 4
Bruise/Contusion 1 1
Death 1 1
Ecchymosis 1 1
Pressure Sores 1 1
Injury 1 1
Skin Inflammation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Ossur Americas II Mar-11-2019
2 Ossur H / F II Apr-19-2016
3 Smith & Nephew, Inc. II Feb-10-2022
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