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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device orthosis, cervical
Product CodeIQK
Regulation Number 890.3490
Device Class 1

MDR Year MDR Reports MDR Events
2018 17 17
2019 1 1
2020 2 2
2021 3 3
2022 2 2
2023 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Fracture 13 13
Adverse Event Without Identified Device or Use Problem 3 3
Detachment of Device or Device Component 2 2
Break 1 1
Detachment Of Device Component 1 1
Component Incompatible 1 1
Positioning Problem 1 1
Pressure Problem 1 1
Patient Device Interaction Problem 1 1
Mechanical Problem 1 1
Material Too Rigid or Stiff 1 1
Inadequacy of Device Shape and/or Size 1 1
Use of Device Problem 1 1
Structural Problem 1 1
Defective Device 1 1
Patient-Device Incompatibility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 14 14
Pressure Sores 3 3
Injury 2 2
Swelling/ Edema 2 2
No Clinical Signs, Symptoms or Conditions 2 2
Insufficient Information 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Brain Injury 1 1
Ulcer 1 1
Pulmonary Embolism 1 1
Erythema 1 1
Fall 1 1
Head Injury 1 1
Irritation 1 1
Pain 1 1
Loss of Range of Motion 1 1
Neck Pain 1 1
Confusion/ Disorientation 1 1
No Known Impact Or Consequence To Patient 1 1
No Information 1 1
No Code Available 1 1
Respiratory Arrest 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Ossur Americas II Dec-15-2021
2 Ossur Americas II Jun-17-2021
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