Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device orthosis, cervical
Product CodeIQK
Regulation Number 890.3490
Device Class 1

MDR Year MDR Reports MDR Events
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
Break 2 2
Detachment of Device or Device Component 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Positioning Problem 1 1
Pressure Problem 1 1
Patient Device Interaction Problem 1 1
Mechanical Problem 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 Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 4 4
Pressure Sores 3 3
Swelling/ Edema 2 2
Insufficient Information 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Injury 1 1
Neck Pain 1 1
No Known Impact Or Consequence To Patient 1 1
Respiratory Arrest 1 1
Pulmonary Embolism 1 1
Irritation 1 1
Loss of Range of Motion 1 1
Ulcer 1 1

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