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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
Regulation Description Limb orthosis.
Product CodeIQI
Regulation Number 890.3475
Device Class 1

MDR Year MDR Reports MDR Events
2015 20 20
2016 14 14
2017 93 93
2018 19 19
2019 19 19
2020 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Material Separation 84 84
Adverse Event Without Identified Device or Use Problem 44 44
Detachment Of Device Component 10 10
Insufficient Information 6 6
Patient Device Interaction Problem 4 4
Device Operates Differently Than Expected 4 4
Device Subassembly 4 4
Fungus in Device Environment 3 3
Device Packaging Compromised 3 3
Mechanical Jam 2 2
Patient-Device Incompatibility 2 2
Break 2 2
Unintended Collision 2 2
Mechanics Altered 2 2
Sharp Edges 1 1
Positioning Problem 1 1
Peeled/Delaminated 1 1
Material Rupture 1 1
Inadequacy of Device Shape and/or Size 1 1
Improper or Incorrect Procedure or Method 1 1
Fitting Problem 1 1
Device Markings/Labelling Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Integrity Problem 1 1
Crack 1 1
Gel Leak 1 1
Device Emits Odor 1 1
Off-Label Use 1 1
Device Slipped 1 1
Component Missing 1 1
Cord 1 1
Loss of or Failure to Bond 1 1
No Apparent Adverse Event 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 65 65
No Consequences Or Impact To Patient 29 29
Itching Sensation 15 15
Skin Irritation 14 14
Rash 10 10
Erythema 8 8
Swelling 8 8
Fall 7 7
Pain 7 7
Injury 5 5
Bone Fracture(s) 5 5
No Patient Involvement 5 5
Unspecified Infection 4 4
Cellulitis 3 3
Numbness 3 3
Ulceration 2 2
Ambulation Difficulties 2 2
Sprain 2 2
Rupture 2 2
Laceration(s) 2 2
Damage to Ligament(s) 2 2
Burning Sensation 2 2
Reaction 2 2
Patient Problem/Medical Problem 2 2
No Information 2 2
No Code Available 2 2
Bacterial Infection 1 1
Post Operative Wound Infection 1 1
Suture Abrasion 1 1
Limited Mobility Of The Implanted Joint 1 1
Infection, Indirect 1 1
Discomfort 1 1
Complaint, Ill-Defined 1 1
Arthralgia 1 1
Joint Disorder 1 1
Local Reaction 1 1
Tissue Damage 1 1
Necrosis 1 1
Purulent Discharge 1 1
Pressure Sores 1 1
Deformity/ Disfigurement 1 1
Spinal Column Injury 1 1
Hypersensitivity/Allergic reaction 1 1
Failure of Implant 1 1
Irritation 1 1
Loss of Range of Motion 1 1
Wound Dehiscence 1 1
Abrasion 1 1
Arthritis 1 1
Burn(s) 1 1
Cyst(s) 1 1
Emotional Changes 1 1
Caustic/Chemical Burns 1 1
Fluid Discharge 1 1
Fungal Infection 1 1

Recalls
Manufacturer Recall Class Date Posted
1 3M Company - Health Care Business II Mar-09-2018
2 DeRoyal Industries Inc II Dec-06-2016
3 Ossur H / F II Mar-31-2016
4 United Surgical Associates II May-23-2015
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