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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

MDR Year MDR Reports MDR Events
2020 37 37
2021 40 40
2022 26 26
2023 18 18
2024 47 47
2025 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Break 43 43
Device-Device Incompatibility 23 23
Unintended Movement 14 14
Adverse Event Without Identified Device or Use Problem 12 12
Detachment of Device or Device Component 10 10
Unstable 8 8
Physical Resistance/Sticking 7 7
Defective Device 7 7
Mechanical Jam 6 6
Positioning Problem 6 6
Patient Device Interaction Problem 5 5
Use of Device Problem 5 5
Material Deformation 5 5
Mechanical Problem 4 4
Insufficient Information 4 4
Positioning Failure 4 4
Material Twisted/Bent 4 4
Manufacturing, Packaging or Shipping Problem 3 3
Naturally Worn 3 3
Fitting Problem 2 2
Device Markings/Labelling Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Device Dislodged or Dislocated 2 2
Material Separation 2 2
Loss of or Failure to Bond 1 1
Corroded 1 1
Difficult to Open or Close 1 1
Connection Problem 1 1
Inadequate or Insufficient Training 1 1
Fracture 1 1
Device Contamination with Chemical or Other Material 1 1
Retraction Problem 1 1
Electromagnetic Compatibility Problem 1 1
Device Unsafe to Use in Environment 1 1
Component Missing 1 1
Material Too Rigid or Stiff 1 1
Material Fragmentation 1 1
Contamination /Decontamination Problem 1 1
Material Integrity Problem 1 1
Device Fell 1 1
Device Alarm System 1 1
Material Frayed 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 122 122
No Known Impact Or Consequence To Patient 13 13
Insufficient Information 13 13
No Consequences Or Impact To Patient 10 10
No Patient Involvement 9 9
Nerve Damage 3 3
Hip Fracture 2 2
Bone Fracture(s) 2 2
Laceration(s) 2 2
Pain 2 2
No Code Available 1 1
Abrasion 1 1
Foreign Body In Patient 1 1
Numbness 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Baxter Healthcare Corporation II Mar-20-2024
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