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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device appliance, fixation, nail/blade/plate combination, single component
Product CodeKTW
Regulation Number 888.3030
Device Class 2


Premarket Reviews
ManufacturerDecision
ADVANCED ORTHOPAEDIC SOLUTIONS, INC
  SUBSTANTIALLY EQUIVALENT 1
ADVANCED ORTHOPAEDIC SOLUTIONS, INC. (AOS)
  SUBSTANTIALLY EQUIVALENT 1
ORTHOFIX SRL
  SUBSTANTIALLY EQUIVALENT 1
PAONAN BIOTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
PARAGON 28, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 62 62
2015 26 26
2016 41 41
2017 27 27
2018 24 24
2019 11 11
2020 60 60
2021 25 25
2022 50 50
2023 30 30
2024 65 65

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 147 147
Break 125 125
Device-Device Incompatibility 16 16
Patient Device Interaction Problem 16 16
Failure to Cut 16 16
Migration or Expulsion of Device 15 15
Fracture 13 13
Fitting Problem 9 9
Material Twisted/Bent 9 9
Device Operates Differently Than Expected 7 7
Migration 7 7
Positioning Failure 7 7
Material Deformation 7 7
Appropriate Term/Code Not Available 5 5
Unintended Movement 4 4
Entrapment of Device 3 3
Failure to Power Up 3 3
Deformation Due to Compressive Stress 2 2
Mechanical Jam 2 2
Device Dislodged or Dislocated 2 2
Detachment of Device or Device Component 2 2
No Apparent Adverse Event 2 2
Sticking 2 2
Defective Device 2 2
Physical Resistance/Sticking 2 2
Use of Device Problem 1 1
Failure to Osseointegrate 1 1
Device Damaged by Another Device 1 1
Bent 1 1
Failure to Align 1 1
Difficult or Delayed Positioning 1 1
Partial Blockage 1 1
Failure To Adhere Or Bond 1 1
Difficult to Remove 1 1
Positioning Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Metal Shedding Debris 1 1
Insufficient Information 1 1
Crack 1 1
Failure to Disconnect 1 1
Operating System Becomes Nonfunctional 1 1
Device Slipped 1 1
Detachment Of Device Component 1 1
Loss of or Failure to Bond 1 1
Component Falling 1 1
Dull, Blunt 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Failure of Implant 82 82
Pain 59 59
Non-union Bone Fracture 54 54
No Code Available 47 47
No Clinical Signs, Symptoms or Conditions 43 43
Insufficient Information 40 40
Impaired Healing 33 33
No Known Impact Or Consequence To Patient 28 28
Unspecified Infection 26 26
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 20 20
Hypersensitivity/Allergic reaction 14 14
Loss of Range of Motion 11 11
Necrosis 10 10
Bone Fracture(s) 10 10
Malunion of Bone 9 9
Arthritis 4 4
No Consequences Or Impact To Patient 4 4
Unspecified Tissue Injury 4 4
Fall 4 4
Foreign Body In Patient 4 4
Nerve Damage 3 3
Post Operative Wound Infection 3 3
Irritation 2 2
Swelling 2 2
Osteolysis 2 2
No Information 2 2
Reaction 2 2
Not Applicable 2 2
Physical Asymmetry 2 2
Fracture, Arm 2 2
Ambulation Difficulties 2 2
Skin Erosion 1 1
Seroma 1 1
Injury 1 1
Spinal Column Injury 1 1
Discomfort 1 1
No Patient Involvement 1 1
Implant Pain 1 1
Inflammation 1 1
Sedation 1 1
Seizures 1 1
Limb Fracture 1 1
Swelling/ Edema 1 1
Joint Dislocation 1 1
Erosion 1 1
Hip Fracture 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Synthes USA (HQ), Inc. II Feb-16-2011
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