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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
Regulation Description Single/multiple component metallic bone fixation appliances and accessories.
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
PAONAN BIOTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
PARAGON 28, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 41 41
2017 27 27
2018 24 24
2019 11 11
2020 60 60
2021 21 21

Device Problems MDRs with this Device Problem Events in those MDRs
Break 72 72
Adverse Event Without Identified Device or Use Problem 48 48
Migration or Expulsion of Device 9 9
Device-Device Incompatibility 8 8
Material Twisted/Bent 8 8
Fitting Problem 7 7
Fracture 7 7
Material Deformation 5 5
Appropriate Term/Code Not Available 4 4
Unintended Movement 3 3
Failure to Power Up 3 3
Device Operates Differently Than Expected 3 3
Sticking 2 2
Patient Device Interaction Problem 2 2
No Apparent Adverse Event 1 1
Insufficient Information 1 1
Operating System Becomes Nonfunctional 1 1
Positioning Problem 1 1
Device Slipped 1 1
Crack 1 1
Bent 1 1
Loss of or Failure to Bond 1 1
Device Damaged by Another Device 1 1
Dull, Blunt 1 1
Failure to Align 1 1
Mechanical Jam 1 1
Device Dislodged or Dislocated 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Failure of Implant 41 41
No Code Available 41 41
Pain 27 27
Non-union Bone Fracture 23 23
Insufficient Information 22 22
No Known Impact Or Consequence To Patient 15 15
Impaired Healing 12 12
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 10 10
Unspecified Infection 10 10
No Clinical Signs, Symptoms or Conditions 8 8
Bone Fracture(s) 5 5
Loss of Range of Motion 5 5
No Consequences Or Impact To Patient 4 4
Necrosis 3 3
Malunion of Bone 3 3
Post Operative Wound Infection 2 2
Ambulation Difficulties 2 2
Not Applicable 2 2
Irritation 2 2
Swelling 2 2
Fracture, Arm 2 2
Discomfort 1 1
Seizures 1 1
Skin Erosion 1 1
Spinal Column Injury 1 1
Nerve Damage 1 1
Inflammation 1 1
Erosion 1 1
Fall 1 1
No Information 1 1
No Patient Involvement 1 1
Reaction 1 1
Unspecified Tissue Injury 1 1
Swelling/ Edema 1 1

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