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 assembly, knee/shank/ankle/foot, external
Product CodeISW
Regulation Number 890.3500
Device Class 2

MDR Year MDR Reports MDR Events
2016 10 10
2017 4 4
2018 3 3
2019 6 6
2021 2 2
2022 2 2
2023 1 1
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Device Operates Differently Than Expected 7 7
Adverse Event Without Identified Device or Use Problem 7 7
Break 3 3
Insufficient Information 3 3
Loose or Intermittent Connection 3 3
Use of Device Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Defective Device 1 1
Deformation Due to Compressive Stress 1 1
Human Factors Issue 1 1
Inadequate User Interface 1 1
Material Twisted/Bent 1 1
Physical Resistance/Sticking 1 1
Electrical /Electronic Property Problem 1 1
Fracture 1 1
Output Problem 1 1
Protective Measures Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Fall 21 21
Bone Fracture(s) 6 6
No Consequences Or Impact To Patient 3 3
Hip Fracture 3 3
Rupture 2 2
Injury 1 1
Bruise/Contusion 1 1
Contusion 1 1
Limb Fracture 1 1
Unspecified Tissue Injury 1 1
Head Injury 1 1
Failure of Implant 1 1
Laceration(s) 1 1
Damage to Ligament(s) 1 1
Pain 1 1
Concussion 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Ossur Americas II Sep-28-2022
2 Ossur H / F II May-10-2024
3 Ossur H / F II Jan-25-2024
-
-