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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 18 18

Device Problems MDRs with this Device Problem Events in those MDRs
Break 28 28
Device-Device Incompatibility 22 22
Adverse Event Without Identified Device or Use Problem 16 16
Positioning Failure 11 11
Unintended Movement 10 10
Device Operates Differently Than Expected 9 9
Unstable 9 9
Material Twisted/Bent 8 8
Positioning Problem 7 7
Mechanical Jam 6 6
Detachment Of Device Component 6 6
Mechanical Problem 6 6
Use of Device Problem 5 5
Physical Resistance/Sticking 5 5
Insufficient Information 4 4
Detachment of Device or Device Component 3 3
Material Deformation 3 3
Device Slipped 3 3
Fracture 3 3
Material Fragmentation 2 2
Loose or Intermittent Connection 2 2
Failure To Adhere Or Bond 2 2
Degraded 2 2
Failure to Align 2 2
Device Markings/Labelling Problem 2 2
Appropriate Term/Code Not Available 2 2
Therapeutic or Diagnostic Output Failure 2 2
Material Separation 2 2
Device Fell 1 1
Patient Device Interaction Problem 1 1
Fitting Problem 1 1
Device Dislodged or Dislocated 1 1
Electromagnetic Compatibility Problem 1 1
Device Contamination with Chemical or Other Material 1 1
Material Integrity Problem 1 1
Material Protrusion/Extrusion 1 1
Device Unsafe to Use in Environment 1 1
Naturally Worn 1 1
Physical Property Issue 1 1
Defective Device 1 1
Patient-Device Incompatibility 1 1
Connection Problem 1 1
Sticking 1 1
Inadequate or Insufficient Training 1 1
Peeled/Delaminated 1 1
Material Too Rigid or Stiff 1 1
Crack 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 58 58
No Known Impact Or Consequence To Patient 51 51
No Consequences Or Impact To Patient 22 22
No Patient Involvement 15 15
No Code Available 8 8
Foreign Body In Patient 4 4
Pain 4 4
Fall 2 2
Unspecified Infection 2 2
Laceration(s) 2 2
Nerve Damage 2 2
Injury 2 2
Insufficient Information 2 2
Device Embedded In Tissue or Plaque 1 1
No Information 1 1
Non-union Bone Fracture 1 1
Numbness 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

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