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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
Product CodeHST
Regulation Number 888.5850
Device Class 1

MDR Year MDR Reports MDR Events
2019 32 32
2020 37 37
2021 40 40
2022 26 26
2023 18 18
2024 42 42

Device Problems MDRs with this Device Problem Events in those MDRs
Break 45 45
Device-Device Incompatibility 22 22
Unintended Movement 14 14
Adverse Event Without Identified Device or Use Problem 12 12
Positioning Failure 12 12
Detachment of Device or Device Component 11 11
Unstable 8 8
Defective Device 7 7
Mechanical Jam 6 6
Mechanical Problem 6 6
Physical Resistance/Sticking 6 6
Material Deformation 6 6
Positioning Problem 6 6
Material Twisted/Bent 6 6
Patient Device Interaction Problem 5 5
Insufficient Information 5 5
Use of Device Problem 5 5
Naturally Worn 4 4
Manufacturing, Packaging or Shipping Problem 3 3
Loose or Intermittent Connection 2 2
Device Dislodged or Dislocated 2 2
Material Separation 2 2
Degraded 2 2
Material Fragmentation 2 2
Therapeutic or Diagnostic Output Failure 2 2
Device Markings/Labelling Problem 2 2
Fitting Problem 2 2
Material Too Rigid or Stiff 1 1
Component Missing 1 1
Material Integrity Problem 1 1
Loss of or Failure to Bond 1 1
Electromagnetic Compatibility Problem 1 1
Device Unsafe to Use in Environment 1 1
Device Fell 1 1
Crack 1 1
Peeled/Delaminated 1 1
Retraction Problem 1 1
Device Contamination with Chemical or Other Material 1 1
Fracture 1 1
Inadequate or Insufficient Training 1 1
Device Alarm System 1 1
Connection Problem 1 1
Difficult to Open or Close 1 1
Material Frayed 1 1
Device Slipped 1 1
Corroded 1 1
Contamination /Decontamination Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 114 114
No Known Impact Or Consequence To Patient 30 30
No Consequences Or Impact To Patient 16 16
Insufficient Information 13 13
No Patient Involvement 12 12
Foreign Body In Patient 4 4
Nerve Damage 3 3
Hip Fracture 2 2
No Code Available 2 2
Bone Fracture(s) 2 2
Laceration(s) 2 2
Pain 2 2
Abrasion 1 1
Injury 1 1
Numbness 1 1
Device Embedded In Tissue or Plaque 1 1

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