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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device orthosis, limb brace
Product CodeIQI
Regulation Number 890.3475
Device Class 1


Premarket Reviews
ManufacturerDecision
NEUROSPECTRUM LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 39 39
2015 20 20
2016 14 14
2017 93 93
2018 19 19
2019 19 19
2020 11 11
2021 9 9
2022 11 11
2023 3 3
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Material Separation 97 97
Adverse Event Without Identified Device or Use Problem 72 72
Detachment Of Device Component 12 12
Insufficient Information 10 10
Patient Device Interaction Problem 8 8
Device Operates Differently Than Expected 7 7
Break 4 4
Fungus in Device Environment 3 3
Inadequacy of Device Shape and/or Size 3 3
Device Packaging Compromised 3 3
Mechanical Jam 2 2
Device Markings/Labelling Problem 2 2
Patient-Device Incompatibility 2 2
Mechanics Altered 2 2
Unintended Collision 2 2
Improper or Incorrect Procedure or Method 1 1
Gel Leak 1 1
Human-Device Interface Problem 1 1
Material Rupture 1 1
Device Emits Odor 1 1
Product Quality Problem 1 1
No Apparent Adverse Event 1 1
Material Protrusion/Extrusion 1 1
Component Missing 1 1
Scratched Material 1 1
Loss of or Failure to Bond 1 1
Component Falling 1 1
Fracture 1 1
Structural Problem 1 1
Sharp Edges 1 1
Therapeutic or Diagnostic Output Failure 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Positioning Problem 1 1
Failure to Obtain Sample 1 1
Material Integrity Problem 1 1
Device Fell 1 1
Peeled/Delaminated 1 1
Crack 1 1
Torn Material 1 1
Off-Label Use 1 1
Fitting Problem 1 1
Device Slipped 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 75 75
No Consequences Or Impact To Patient 31 31
Itching Sensation 22 22
Skin Irritation 17 17
Erythema 14 14
Rash 14 14
Irritation 11 11
Pain 10 10
Fall 9 9
Swelling 9 9
Skin Inflammation/ Irritation 8 8
Injury 6 6
Bone Fracture(s) 6 6
Unspecified Infection 5 5
Laceration(s) 5 5
No Patient Involvement 5 5
Numbness 5 5
Pressure Sores 3 3
Cellulitis 3 3
Blister 3 3
Abrasion 3 3
No Information 3 3
No Clinical Signs, Symptoms or Conditions 3 3
Hypersensitivity/Allergic reaction 3 3
Sprain 2 2
Bruise/Contusion 2 2
Ambulation Difficulties 2 2
Inflammation 2 2
Rupture 2 2
Bacterial Infection 2 2
Damage to Ligament(s) 2 2
Patient Problem/Medical Problem 2 2
Fungal Infection 2 2
No Code Available 2 2
Burn(s) 2 2
Burning Sensation 2 2
Thrombosis 2 2
Ulceration 2 2
Discomfort 2 2
Reaction 2 2
Insufficient Information 2 2
Nerve Damage 2 2
Joint Dislocation 2 2
Skin Burning Sensation 1 1
Arthritis 1 1
Hemorrhage/Bleeding 1 1
Deformity/ Disfigurement 1 1
Skin Tears 1 1
Caustic/Chemical Burns 1 1
Tissue Damage 1 1

Recalls
Manufacturer Recall Class Date Posted
1 3M Company - Health Care Business II Mar-09-2018
2 Breg Inc II Apr-10-2014
3 DeRoyal Industries Inc II Dec-06-2016
4 Ossur H / F II Mar-31-2016
5 Townsend Design II Jan-05-2024
6 United Surgical Associates II May-23-2015
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