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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device pin, fixation, threaded
Regulation Description Smooth or threaded metallic bone fixation fastener.
Product CodeJDW
Regulation Number 888.3040
Device Class 2


Premarket Reviews
ManufacturerDecision
EISERTECH, LLC
  SUBSTANTIALLY EQUIVALENT 1
SYNTEC SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2015 70 70
2016 46 46
2017 43 43
2018 94 94
2019 575 575
2020 311 311

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 613 613
Break 128 128
Insufficient Information 86 86
Mechanical Problem 66 66
Fracture 51 51
Patient Device Interaction Problem 45 45
Migration 29 29
Tip 26 26
Pin 19 19
Loose or Intermittent Connection 17 17
Clamp 17 17
Appropriate Term/Code Not Available 16 16
Patient-Device Incompatibility 16 16
Malposition of Device 14 14
Detachment Of Device Component 13 13
Device Dislodged or Dislocated 11 11
Material Fragmentation 11 11
Screw 9 9
Bent 9 9
Dull, Blunt 9 9
Loosening of Implant Not Related to Bone-Ingrowth 8 8
Mechanical Jam 7 7
Detachment of Device or Device Component 5 5
Crack 5 5
Cutter/Blade 5 5
Device Operates Differently Than Expected 4 4
Product Quality Problem 4 4
Contamination 4 4
Entrapment of Device 4 4
Motor(s) 4 4
Device-Device Incompatibility 4 4
Material Integrity Problem 3 3
Wire 3 3
Loss of Osseointegration 3 3
Defective Component 3 3
Human-Device Interface Problem 3 3
Material Twisted/Bent 2 2
Device Packaging Compromised 2 2
No Apparent Adverse Event 2 2
Difficult to Remove 2 2
Frame 2 2
Device Markings/Labelling Problem 2 2
Physical Resistance/Sticking 2 2
Unintended Movement 2 2
Difficult to Advance 2 2
Device Contaminated During Manufacture or Shipping 2 2
Material Deformation 2 2
Contamination /Decontamination Problem 1 1
Device Contamination With Biological Material 1 1
Compatibility Problem 1 1
Incorrect Device Or Component Shipped 1 1
Switch, Push Button 1 1
Positioning Problem 1 1
Connector 1 1
Material Frayed 1 1
Difficult to Insert 1 1
Tear, Rip or Hole in Device Packaging 1 1
Sticking 1 1
Improper or Incorrect Procedure or Method 1 1
Fitting Problem 1 1
Material Separation 1 1
Shelf Life Exceeded 1 1
Failure to Osseointegrate 1 1
Microbial Contamination of Device 1 1
Component Missing 1 1
Migration or Expulsion of Device 1 1
Plate 1 1
Bolt 1 1
Collapse 1 1
Device Damaged by Another Device 1 1
Activation, Positioning or SeparationProblem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 385 385
Injury 201 201
No Code Available 143 143
No Known Impact Or Consequence To Patient 118 118
Post Operative Wound Infection 102 102
No Information 62 62
Device Embedded In Tissue or Plaque 52 52
Inflammation 51 51
Bacterial Infection 45 45
Non-union Bone Fracture 34 34
Pain 31 31
No Consequences Or Impact To Patient 29 29
Erythema 24 24
Failure of Implant 18 18
Foreign Body In Patient 18 18
Bone Fracture(s) 12 12
Irritation 12 12
Swelling 10 10
Impaired Healing 10 10
Thrombosis 9 9
Loss of Range of Motion 8 8
Nerve Damage 7 7
Tissue Damage 6 6
Purulent Discharge 6 6
Discharge 6 6
Arthritis 5 5
Fluid Discharge 5 5
Hemorrhage/Bleeding 5 5
Tissue Breakdown 5 5
Cellulitis 4 4
Sedation 4 4
Joint Dislocation 4 4
Fall 4 4
Abscess 3 3
Hip Fracture 3 3
Perforation 3 3
Ambulation Difficulties 3 3
Tingling 3 3
No Patient Involvement 3 3
Complaint, Ill-Defined 2 2
Blood Loss 2 2
Ossification 2 2
Necrosis 2 2
No Clinical Signs, Symptoms or Conditions 2 2
Oversedation 2 2
Hypersensitivity/Allergic reaction 1 1
Pulmonary Embolism 1 1
Burn(s) 1 1
Fracture, Arm 1 1
Deformity/ Disfigurement 1 1
Hernia 1 1
Numbness 1 1
Death 1 1
Embolism 1 1
Discomfort 1 1
Vascular System (Circulation), Impaired 1 1
Not Applicable 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Musculoskeletal Transplant Foundation, Inc. II Jul-24-2015
2 Orthofix Srl II Nov-14-2019
3 Zimmer Biomet, Inc. II Dec-29-2017
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