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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
Product CodeHTY
Regulation Number 888.3040
Device Class 2


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

MDR Year MDR Reports MDR Events
2018 138 138
2019 222 222
2020 210 210
2021 149 149
2022 95 95

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 344 344
Break 173 173
Fracture 63 63
Mechanical Jam 44 44
Material Twisted/Bent 19 19
Insufficient Information 18 18
Device-Device Incompatibility 14 14
Entrapment of Device 14 14
Detachment of Device or Device Component 13 13
Appropriate Term/Code Not Available 12 12
Material Deformation 11 11
Migration 11 11
Patient-Device Incompatibility 10 10
Separation Failure 10 10
Loose or Intermittent Connection 9 9
Physical Resistance/Sticking 9 9
Material Fragmentation 7 7
Migration or Expulsion of Device 7 7
Device Operates Differently Than Expected 7 7
Device Slipped 6 6
Improper or Incorrect Procedure or Method 6 6
Use of Device Problem 5 5
Difficult to Remove 5 5
Device Dislodged or Dislocated 5 5
Malposition of Device 5 5
Patient Device Interaction Problem 5 5
Positioning Problem 5 5
Material Split, Cut or Torn 5 5
Therapeutic or Diagnostic Output Failure 4 4
Activation Failure 4 4
Manufacturing, Packaging or Shipping Problem 4 4
Difficult to Advance 4 4
Expiration Date Error 4 4
Failure to Power Up 4 4
Unstable 4 4
Product Quality Problem 3 3
Defective Device 3 3
Device Displays Incorrect Message 3 3
Unintended Movement 3 3
Output Problem 3 3
Naturally Worn 2 2
Material Protrusion/Extrusion 2 2
Failure to Advance 2 2
Component Missing 2 2
Material Rupture 2 2
Inadequacy of Device Shape and/or Size 2 2
Failure to Osseointegrate 2 2
Difficult to Insert 2 2
Delivered as Unsterile Product 2 2
Nonstandard Device 1 1
Image Display Error/Artifact 1 1
Mechanical Problem 1 1
Device Expiration Issue 1 1
Flaked 1 1
Bent 1 1
Partial Blockage 1 1
Corroded 1 1
Positioning Failure 1 1
Disconnection 1 1
No Display/Image 1 1
Display or Visual Feedback Problem 1 1
Electrical /Electronic Property 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
Shipping Damage or Problem 1 1
Smoking 1 1
Unraveled Material 1 1
Tear, Rip or Hole in Device Packaging 1 1
Failure to Align 1 1
Failure to Cut 1 1
Difficult to Open or Close 1 1
Connection Problem 1 1
Packaging Problem 1 1
No Apparent Adverse Event 1 1
Loosening of Implant Not Related to Bone-Ingrowth 1 1
Device Fell 1 1
Separation Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 97 97
Unspecified Infection 97 97
No Clinical Signs, Symptoms or Conditions 75 75
No Code Available 62 62
Pain 51 51
Injury 45 45
No Known Impact Or Consequence To Patient 42 42
Swelling/ Edema 42 42
Failure of Implant 40 40
Non-union Bone Fracture 38 38
Insufficient Information 35 35
Foreign Body In Patient 33 33
Not Applicable 31 31
Implant Pain 30 30
Post Operative Wound Infection 27 27
Tissue Damage 26 26
No Patient Involvement 25 25
Discomfort 25 25
Device Embedded In Tissue or Plaque 20 20
Cellulitis 14 14
Swelling 14 14
Impaired Healing 12 12
Bone Fracture(s) 10 10
No Information 9 9
Unspecified Tissue Injury 9 9
Loss of Range of Motion 9 9
Inflammation 9 9
Necrosis 7 7
Joint Disorder 5 5
Organ Dehiscence 5 5
Thrombosis 5 5
Nerve Damage 5 5
Physical Asymmetry 5 5
Deformity/ Disfigurement 4 4
Unspecified Musculoskeletal problem 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Patient Problem/Medical Problem 4 4
Bacterial Infection 3 3
Malunion of Bone 3 3
Skin Inflammation/ Irritation 3 3
Hypersensitivity/Allergic reaction 3 3
Fall 3 3
Pulmonary Embolism 3 3
Arthritis 3 3
Wound Dehiscence 3 3
Erythema 3 3
Fracture, Arm 3 3
Neuropathy 2 2
Rash 2 2
Sepsis 2 2
Synovitis 2 2
Adhesion(s) 2 2
Erosion 2 2
Cyst(s) 2 2
Fluid Discharge 2 2
Hypoesthesia 2 2
Osteolysis 2 2
Joint Laxity 2 2
Edema 2 2
Foreign Body Reaction 1 1
Muscular Rigidity 1 1
Weight Changes 1 1
Thromboembolism 1 1
Joint Contracture 1 1
Hematoma 1 1
Irritation 1 1
Embolus 1 1
Laceration(s) 1 1
Pleural Effusion 1 1
Needle Stick/Puncture 1 1
Skin Irritation 1 1
Perforation 1 1
Fatigue 1 1
Fever 1 1
Abscess 1 1
Joint Dislocation 1 1
Sweating 1 1
Rupture 1 1
Ulcer 1 1
Hip Fracture 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Brasseler USA I Lp II Jan-29-2020
2 Brasseler USA, Medical L.L.C. II Mar-01-2022
3 Paragon 28, Inc. II Jul-27-2022
4 Stryker GmbH II Apr-27-2022
5 Trilliant Surgical, LLC II Apr-01-2020
6 Zimmer Biomet, Inc. II Jun-01-2018
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