• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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
STL INTL
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2015 37 37
2016 28 28
2017 20 20
2018 25 25
2019 32 32
2020 28 28

Device Problems MDRs with this Device Problem Events in those MDRs
Device Operates Differently Than Expected 27 27
Break 22 22
Adverse Event Without Identified Device or Use Problem 18 18
Fitting Problem 11 11
Positioning Failure 11 11
Mechanical Jam 11 11
Detachment Of Device Component 9 9
Failure To Adhere Or Bond 8 8
Failure to Align 8 8
Device-Device Incompatibility 7 7
Positioning Problem 6 6
Device Slipped 5 5
Use of Device Problem 4 4
Detachment of Device or Device Component 4 4
Material Twisted/Bent 4 4
Sticking 4 4
Loose or Intermittent Connection 3 3
Difficult to Advance 3 3
Mechanical Problem 3 3
Material Separation 3 3
Fracture 3 3
Degraded 2 2
Insufficient Information 2 2
Appropriate Term/Code Not Available 2 2
Material Deformation 2 2
Device Subassembly 2 2
Physical Resistance/Sticking 1 1
Device Fell 1 1
Material Integrity Problem 1 1
Mechanics Altered 1 1
Pressure Problem 1 1
Unintended Movement 1 1
Peeled/Delaminated 1 1
Knob 1 1
Unstable 1 1
Connection Problem 1 1
Device Markings/Labelling Problem 1 1
Noise, Audible 1 1
Device Issue 1 1
Device Dislodged or Dislocated 1 1
Material Protrusion/Extrusion 1 1
Naturally Worn 1 1
Physical Property Issue 1 1
Therapeutic or Diagnostic Output Failure 1 1
Bed, Assist Bar 1 1
Locking Mechanism 1 1
Material Too Rigid or Stiff 1 1
Separation Failure 1 1
Patient-Device Incompatibility 1 1
Component or Accessory Incompatibility 1 1
Material Fragmentation 1 1
Labelling, Instructions for Use or Training Problem 1 1
Disassembly 1 1
Crack 1 1
Plate 1 1
Bent 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 86 86
No Consequences Or Impact To Patient 23 23
No Patient Involvement 19 19
No Code Available 10 10
Bruise/Contusion 4 4
Pain 4 4
Fall 4 4
Failure of Implant 3 3
Sedation 3 3
Foreign Body In Patient 3 3
Head Injury 3 3
Unspecified Infection 3 3
Injury 3 3
Non-union Bone Fracture 2 2
Numbness 2 2
Swelling 2 2
Visual Disturbances 1 1
Loss of Range of Motion 1 1
Abrasion 1 1
Osteolysis 1 1
Impaired Healing 1 1
Nerve Damage 1 1
Device Embedded In Tissue or Plaque 1 1
No Information 1 1
Paralysis 1 1
Visual Impairment 1 1
Brain Injury 1 1
Discomfort 1 1
Death 1 1
Eye Injury 1 1
Bone Fracture(s) 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
3 Dick's Sporting Goods II Jan-20-2015
-
-