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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device joint, knee, external brace
Product CodeITQ
Regulation Number 890.3475
Device Class 1

MDR Year MDR Reports MDR Events
2018 12 12
2019 76 76
2020 22 22
2021 4 4
2022 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 78 78
Patient Device Interaction Problem 9 9
Break 6 6
Detachment of Device or Device Component 3 3
No Apparent Adverse Event 3 3
Insufficient Information 2 2
Collapse 2 2
Material Twisted/Bent 2 2
Inadequacy of Device Shape and/or Size 2 2
Physical Resistance/Sticking 2 2
Device Fell 1 1
Unexpected Therapeutic Results 1 1
Unstable 1 1
Material Integrity Problem 1 1
Unintended Movement 1 1
Mechanical Jam 1 1
Component Incompatible 1 1
Fracture 1 1
Patient-Device Incompatibility 1 1
Device Operates Differently Than Expected 1 1
Crack 1 1
Mechanical Problem 1 1
Device Slipped 1 1
Use of Device Problem 1 1
Defective Device 1 1
Loose or Intermittent Connection 1 1
Contamination /Decontamination Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Damage to Ligament(s) 64 64
Injury 13 13
No Consequences Or Impact To Patient 5 5
Fall 5 5
Tissue Damage 4 4
Patient Problem/Medical Problem 3 3
Bone Fracture(s) 3 3
No Known Impact Or Consequence To Patient 3 3
Insufficient Information 3 3
Joint Dislocation 2 2
Swelling 2 2
Thrombosis 1 1
Convulsion, Tonic 1 1
Thrombosis/Thrombus 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Hematoma 1 1
Hypersensitivity/Allergic reaction 1 1
Inflammation 1 1
Unspecified Tissue Injury 1 1
Convulsion, Clonic 1 1
Bruise/Contusion 1 1
Edema 1 1
Ambulation Difficulties 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Hip Fracture 1 1
Neuropathy 1 1
Rash 1 1
Sprain 1 1
Laceration(s) 1 1
Pain 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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