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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
2017 20 20
2018 25 25
2019 32 32
2020 37 37
2021 40 40
2022 9 9

Device Problems MDRs with this Device Problem Events in those MDRs
Break 28 28
Device-Device Incompatibility 17 17
Adverse Event Without Identified Device or Use Problem 16 16
Positioning Failure 11 11
Unintended Movement 10 10
Unstable 9 9
Device Operates Differently Than Expected 9 9
Material Twisted/Bent 8 8
Positioning Problem 7 7
Mechanical Jam 6 6
Detachment Of Device Component 6 6
Physical Resistance/Sticking 5 5
Mechanical Problem 5 5
Use of Device Problem 5 5
Detachment of Device or Device Component 3 3
Device Slipped 3 3
Insufficient Information 3 3
Material Deformation 3 3
Fracture 3 3
Material Separation 2 2
Failure To Adhere Or Bond 2 2
Appropriate Term/Code Not Available 2 2
Degraded 2 2
Therapeutic or Diagnostic Output Failure 2 2
Failure to Align 2 2
Loose or Intermittent Connection 2 2
Device Markings/Labelling Problem 2 2
Device Unsafe to Use in Environment 1 1
Electromagnetic Compatibility Problem 1 1
Connection Problem 1 1
Naturally Worn 1 1
Physical Property Issue 1 1
Crack 1 1
Material Integrity Problem 1 1
Device Fell 1 1
Peeled/Delaminated 1 1
Sticking 1 1
Fitting Problem 1 1
Inadequate or Insufficient Training 1 1
Patient-Device Incompatibility 1 1
Material Protrusion/Extrusion 1 1
Material Fragmentation 1 1
Material Too Rigid or Stiff 1 1
Patient Device Interaction Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 51 51
No Clinical Signs, Symptoms or Conditions 49 49
No Consequences Or Impact To Patient 22 22
No Patient Involvement 15 15
No Code Available 8 8
Pain 4 4
Foreign Body In Patient 3 3
Unspecified Infection 2 2
Laceration(s) 2 2
Nerve Damage 2 2
Injury 2 2
Fall 2 2
Insufficient Information 2 2
Device Embedded In Tissue or Plaque 1 1
No Information 1 1
Head Injury 1 1
Abrasion 1 1
Eye Injury 1 1
Loss of Range of Motion 1 1
Swelling 1 1
Visual Impairment 1 1
Visual Disturbances 1 1
Non-union Bone Fracture 1 1
Numbness 1 1

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