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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device joint, knee, external brace
Product CodeITQ
Regulation Number 890.3475
Device Class 1

MDR Year MDR Reports MDR Events
2019 76 76
2020 22 22
2021 4 4
2022 5 5
2023 75 75
2024 47 47

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Problem 119 119
Unintended System Motion 118 118
Adverse Event Without Identified Device or Use Problem 75 75
No Apparent Adverse Event 24 24
Patient Device Interaction Problem 8 8
Break 5 5
Detachment of Device or Device Component 3 3
Patient-Device Incompatibility 2 2
Collapse 2 2
Insufficient Information 2 2
Defective Device 2 2
Fracture 2 2
Material Twisted/Bent 2 2
Physical Resistance/Sticking 1 1
Inadequacy of Device Shape and/or Size 1 1
Unexpected Therapeutic Results 1 1
Loose or Intermittent Connection 1 1
Device Slipped 1 1
Unstable 1 1
Crack 1 1
Device Fell 1 1
Unintended Movement 1 1
Defective Component 1 1
Material Integrity Problem 1 1
Misassembled During Installation 1 1
Contamination /Decontamination Problem 1 1
Component Incompatible 1 1
Use of Device Problem 1 1
Failure to Align 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 119 119
Damage to Ligament(s) 62 62
Injury 9 9
Fall 6 6
No Consequences Or Impact To Patient 4 4
Patient Problem/Medical Problem 3 3
No Known Impact Or Consequence To Patient 3 3
Insufficient Information 3 3
Pain 3 3
Laceration(s) 3 3
Tissue Damage 3 3
Joint Dislocation 2 2
Bone Fracture(s) 2 2
Hematoma 2 2
Swelling 2 2
Neuropathy 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Convulsion, Clonic 1 1
Hypersensitivity/Allergic reaction 1 1
Hip Fracture 1 1
Fungal Infection 1 1
Sprain 1 1
Inflammation 1 1
Edema 1 1
Blister 1 1
Convulsion, Tonic 1 1
Rash 1 1
Thrombosis/Thrombus 1 1
Limb Fracture 1 1
Unspecified Tissue Injury 1 1
Swelling/ Edema 1 1
Skin Tears 1 1
Ambulation Difficulties 1 1

Recalls
Manufacturer Recall Class Date Posted
1 DeRoyal Industries Inc II Dec-19-2019
2 Mueller Sports Medicine, Inc II Jun-30-2020
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