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TPLC
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show TPLC since
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Device
orthosis, cervical
Product Code
IQK
Regulation Number
890.3490
Device Class
1
MDR Year
MDR Reports
MDR Events
2014
7
7
2015
7
7
2016
20
20
2017
11
11
2018
17
17
2019
1
1
2020
2
2
2021
3
3
2022
2
2
2023
4
4
2024
2
2
Device Problems
MDRs with this Device Problem
Events in those MDRs
Fracture
32
32
Break
9
9
Adverse Event Without Identified Device or Use Problem
8
8
Insufficient Information
4
4
Patient-Device Incompatibility
4
4
Detachment of Device or Device Component
2
2
Incorrect Device Or Component Shipped
2
2
Poor Quality Image
2
2
Difficult To Position
1
1
Product Quality 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
Improper or Incorrect Procedure or Method
1
1
Component Missing
1
1
Structural Problem
1
1
Defective Device
1
1
Material Deformation
1
1
Material Integrity Problem
1
1
Device Operates Differently Than Expected
1
1
Detachment Of Device Component
1
1
Component Incompatible
1
1
Mechanical Problem
1
1
Patient Device Interaction Problem
1
1
Positioning Problem
1
1
Pressure Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
23
23
No Known Impact Or Consequence To Patient
22
22
Pressure Sores
8
8
No Clinical Signs, Symptoms or Conditions
4
4
Injury
3
3
No Information
3
3
No Code Available
3
3
Tissue Breakdown
2
2
Swelling/ Edema
2
2
Ulcer
2
2
Pain
2
2
Skin Irritation
2
2
Swelling
1
1
Tissue Damage
1
1
Loss of Range of Motion
1
1
Urticaria
1
1
Brain Injury
1
1
Pulmonary Embolism
1
1
Abrasion
1
1
Erythema
1
1
Fall
1
1
Bone Fracture(s)
1
1
Head Injury
1
1
Unspecified Infection
1
1
Inflammation
1
1
Irritation
1
1
Itching Sensation
1
1
Insufficient Information
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Respiratory Arrest
1
1
Spinal Cord Injury
1
1
Neck Pain
1
1
Low Oxygen Saturation
1
1
Confusion/ Disorientation
1
1
Blood Loss
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Ossur Americas
II
Dec-15-2021
2
Ossur Americas
II
Jun-17-2021
3
Ossur H / F
II
Mar-31-2016
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