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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device apparatus, traction, non-powered
Regulation Description Nonpowered orthopedic traction apparatus and accessories.
Product CodeHST
Regulation Number 888.5850
Device Class 1


Premarket Reviews
ManufacturerDecision
STL INTERNATIONAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 28 28
2017 20 20
2018 25 25
2019 32 32
2020 37 37
2021 28 28

Device Problems MDRs with this Device Problem Events in those MDRs
Break 23 23
Device Operates Differently Than Expected 17 17
Adverse Event Without Identified Device or Use Problem 16 16
Positioning Failure 11 11
Unintended Movement 10 10
Unstable 9 9
Device-Device Incompatibility 9 9
Fitting Problem 8 8
Mechanical Jam 8 8
Material Twisted/Bent 7 7
Positioning Problem 7 7
Detachment Of Device Component 7 7
Failure To Adhere Or Bond 5 5
Physical Resistance/Sticking 5 5
Device Slipped 5 5
Use of Device Problem 4 4
Mechanical Problem 4 4
Material Separation 3 3
Fracture 3 3
Failure to Align 3 3
Detachment of Device or Device Component 3 3
Difficult to Advance 3 3
Material Deformation 3 3
Sticking 2 2
Loose or Intermittent Connection 2 2
Degraded 2 2
Therapeutic or Diagnostic Output Failure 2 2
Insufficient Information 2 2
Appropriate Term/Code Not Available 2 2
Noise, Audible 1 1
Naturally Worn 1 1
Physical Property Issue 1 1
Material Too Rigid or Stiff 1 1
Material Fragmentation 1 1
Crack 1 1
Material Protrusion/Extrusion 1 1
Separation Failure 1 1
Patient-Device Incompatibility 1 1
Device Issue 1 1
Peeled/Delaminated 1 1
Material Integrity Problem 1 1
Device Fell 1 1
Connection Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 71 71
No Clinical Signs, Symptoms or Conditions 32 32
No Consequences Or Impact To Patient 22 22
No Patient Involvement 18 18
No Code Available 8 8
Foreign Body In Patient 3 3
Unspecified Infection 3 3
Pain 3 3
Fall 3 3
Failure of Implant 3 3
Swelling 2 2
Numbness 2 2
Injury 2 2
Nerve Damage 2 2
Head Injury 2 2
Device Embedded In Tissue or Plaque 1 1
No Information 1 1
Eye Injury 1 1
Bone Fracture(s) 1 1
Non-union Bone Fracture 1 1
Paralysis 1 1
Visual Impairment 1 1
Insufficient Information 1 1
Visual Disturbances 1 1
Loss of Range of Motion 1 1
Abrasion 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Allen Medical Systems, Inc. II Feb-14-2017
2 Allen Medical Systems, Inc. II Dec-29-2016
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