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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device joint, ankle, external brace
Regulation Description Limb orthosis.
Product CodeITW
Regulation Number 890.3475
Device Class 1

MDR Year MDR Reports MDR Events
2016 13 13
2017 8 8
2018 12 12
2019 8 8
2020 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 17 17
Insufficient Information 5 5
Patient Device Interaction Problem 3 3
Fracture 3 3
Inadequacy of Device Shape and/or Size 3 3
Unstable 2 2
Malposition of Device 2 2
Use of Device Problem 2 2
Device Operates Differently Than Expected 2 2
Naturally Worn 1 1
Patient-Device Incompatibility 1 1
Material Separation 1 1
Loss of or Failure to Bond 1 1
Break 1 1
Collapse 1 1
Crack 1 1
Improper or Incorrect Procedure or Method 1 1
Unintended Movement 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pressure Sores 7 7
Bruise/Contusion 4 4
Tissue Damage 4 4
Injury 2 2
Damage to Ligament(s) 2 2
Tissue Breakdown 2 2
Patient Problem/Medical Problem 2 2
No Information 2 2
Reaction 2 2
Sprain 2 2
Swelling 2 2
Thrombosis 2 2
No Consequences Or Impact To Patient 1 1
Ulcer 1 1
Fall 1 1
Fungus 1 1
Rash 1 1
Skin Discoloration 1 1
Skin Irritation 1 1
No Known Impact Or Consequence To Patient 1 1
Post Operative Wound Infection 1 1
No Code Available 1 1
Pain 1 1
Scarring 1 1
Impaired Healing 1 1
Bone Fracture(s) 1 1
Hemorrhage/Bleeding 1 1
Unspecified Infection 1 1
Laceration(s) 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Ossur H / F II Mar-31-2016
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