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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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


Premarket Reviews
ManufacturerDecision
4WEB, INC.
  SUBSTANTIALLY EQUIVALENT 1
A.M. SURGICAL, INC
  SUBSTANTIALLY EQUIVALENT 1
ARMIS BIOPHARMA, INC.
  SUBSTANTIALLY EQUIVALENT 1
ARTHREX INC.
  SUBSTANTIALLY EQUIVALENT 2
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 1
IN2BONES SAS
  SUBSTANTIALLY EQUIVALENT 1
IN2BONES USA, LLC
  SUBSTANTIALLY EQUIVALENT 1
LIMACORPORATE S.P.A.
  SUBSTANTIALLY EQUIVALENT 1
NEWCLIP TECHNICS
  SUBSTANTIALLY EQUIVALENT 1
ORTHOFIX SRL
  SUBSTANTIALLY EQUIVALENT 1
ORTHOPEDIATRICS CORP.
  SUBSTANTIALLY EQUIVALENT 1
OSSIO LTD.
  SUBSTANTIALLY EQUIVALENT 4
PARAGON 28
  SUBSTANTIALLY EQUIVALENT 1
PARAGON 28, INC.
  SUBSTANTIALLY EQUIVALENT 1
PRECIFIT MEDICAL LTD
  SUBSTANTIALLY EQUIVALENT 1
RESTOR3D
  SUBSTANTIALLY EQUIVALENT 1
SKELETAL DYNAMICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER GMBH
  SUBSTANTIALLY EQUIVALENT 1
STRYKER TRAUMA GMBH
  SUBSTANTIALLY EQUIVALENT 1
WISHBONE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 82 82
2018 138 138
2019 222 222
2020 210 210
2021 145 145

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 329 329
Break 167 167
Fracture 64 64
Mechanical Jam 46 46
Material Twisted/Bent 18 18
Device-Device Incompatibility 13 13
Entrapment of Device 13 13
Insufficient Information 13 13
Appropriate Term/Code Not Available 13 13
Material Deformation 12 12
Patient-Device Incompatibility 10 10
Device Operates Differently Than Expected 10 10
Migration or Expulsion of Device 10 10
Material Fragmentation 9 9
Detachment of Device or Device Component 9 9
Separation Failure 8 8
Loose or Intermittent Connection 8 8
Device Slipped 8 8
Migration 8 8
Physical Resistance/Sticking 8 8
Difficult to Remove 7 7
Device Dislodged or Dislocated 7 7
Activation Failure 6 6
Patient Device Interaction Problem 5 5
Malposition of Device 5 5
Expiration Date Error 4 4
Component Missing 4 4
Manufacturing, Packaging or Shipping Problem 4 4
Difficult to Advance 4 4
Therapeutic or Diagnostic Output Failure 4 4
Unstable 4 4
Improper or Incorrect Procedure or Method 4 4
Difficult to Insert 4 4
Device Expiration Issue 4 4
Bent 3 3
Detachment Of Device Component 3 3
Use of Device Problem 3 3
Failure to Power Up 3 3
Positioning Problem 3 3
Material Protrusion/Extrusion 3 3
Failure to Advance 3 3
Device Displays Incorrect Message 3 3
Defective Device 2 2
Tear, Rip or Hole in Device Packaging 2 2
Naturally Worn 2 2
Unintended Movement 2 2
Output Problem 2 2
Shipping Damage or Problem 2 2
Material Rupture 2 2
Failure to Osseointegrate 2 2
Delivered as Unsterile Product 2 2
Nonstandard Device 1 1
Mechanical Problem 1 1
Image Display Error/Artifact 1 1
Corroded 1 1
Positioning Failure 1 1
No Display/Image 1 1
Display or Visual Feedback Problem 1 1
Electrical /Electronic Property Problem 1 1
Partial Blockage 1 1
Flaked 1 1
Smoking 1 1
Unraveled Material 1 1
Fitting Problem 1 1
Visual Prompts will not Clear 1 1
Device Damaged Prior to Use 1 1
Microbial Contamination of Device 1 1
Material Separation 1 1
Shelf Life Exceeded 1 1
Inadequacy of Device Shape and/or Size 1 1
Material Puncture/Hole 1 1
Packaging Problem 1 1
Physical Property Issue 1 1
No Apparent Adverse Event 1 1
Difficult to Open or Close 1 1
Cut In Material 1 1
Failure to Align 1 1
Failure to Cut 1 1
Connection Problem 1 1
Device Disinfection Or Sterilization Issue 1 1
Loosening of Implant Not Related to Bone-Ingrowth 1 1
Device Fell 1 1
Material Split, Cut or Torn 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 101 101
Unspecified Infection 97 97
No Code Available 77 77
No Known Impact Or Consequence To Patient 63 63
Pain 55 55
Injury 45 45
No Clinical Signs, Symptoms or Conditions 43 43
Failure of Implant 38 38
No Patient Involvement 34 34
Non-union Bone Fracture 33 33
Not Applicable 31 31
Implant Pain 30 30
Swelling/ Edema 30 30
Foreign Body In Patient 29 29
Post Operative Wound Infection 27 27
Tissue Damage 27 27
Device Embedded In Tissue or Plaque 25 25
Insufficient Information 19 19
No Information 16 16
Impaired Healing 16 16
Discomfort 16 16
Swelling 14 14
Cellulitis 14 14
Bone Fracture(s) 12 12
Loss of Range of Motion 9 9
Inflammation 9 9
Unspecified Tissue Injury 9 9
Necrosis 6 6
Nerve Damage 5 5
Thrombosis 5 5
Organ Dehiscence 5 5
Joint Disorder 5 5
Physical Asymmetry 5 5
Patient Problem/Medical Problem 4 4
Fall 4 4
Wound Dehiscence 4 4
Pulmonary Embolism 3 3
Arthritis 3 3
Bacterial Infection 3 3
Erythema 3 3
Hypersensitivity/Allergic reaction 3 3
Malunion of Bone 3 3
Deformity/ Disfigurement 3 3
Fracture, Arm 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Hypoesthesia 2 2
Osteolysis 2 2
Skin Inflammation/ Irritation 2 2
Fluid Discharge 2 2
Irritation 2 2
Synovitis 2 2
Rash 2 2
Adhesion(s) 2 2
Cyst(s) 2 2
Edema 2 2
Embolus 1 1
Erosion 1 1
Abscess 1 1
Hematoma 1 1
Fatigue 1 1
Fever 1 1
Foreign Body Reaction 1 1
Skin Irritation 1 1
Perforation 1 1
Pleural Effusion 1 1
Laceration(s) 1 1
Neuropathy 1 1
Joint Laxity 1 1
Joint Contracture 1 1
Weight Changes 1 1
Thromboembolism 1 1
Joint Dislocation 1 1
Sweating 1 1
Needle Stick/Puncture 1 1
Hip Fracture 1 1
Complaint, Ill-Defined 1 1
Rupture 1 1
Ulcer 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Brasseler USA I Lp II Jan-29-2020
2 MicroAire Surgical Instruments, LLC II Mar-03-2017
3 Trilliant Surgical, LLC II Apr-01-2020
4 Zimmer Biomet, Inc. II Jun-01-2018
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