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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
ARMIS BIOPHARMA, INC.
  SUBSTANTIALLY EQUIVALENT 1
ARTHREX INC.
  SUBSTANTIALLY EQUIVALENT 2
ELECTRO-SPEC, INC
  SUBSTANTIALLY EQUIVALENT 1
IN2BONES USA, LLC
  SUBSTANTIALLY EQUIVALENT 1
INTELIVATION
  SUBSTANTIALLY EQUIVALENT 1
LIMACORPORATE S.P.A.
  SUBSTANTIALLY EQUIVALENT 1
ORTHOPEDIATRICS CORP.
  SUBSTANTIALLY EQUIVALENT 1
OSSIO LTD.
  SUBSTANTIALLY EQUIVALENT 6
PACIFIC INSTRUMENTS
  SUBSTANTIALLY EQUIVALENT 1
PARAGON 28, INC.
  SUBSTANTIALLY EQUIVALENT 1
RESTOR3D
  SUBSTANTIALLY EQUIVALENT 1
SKELETAL DYNAMICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER GMBH
  SUBSTANTIALLY EQUIVALENT 1
TYBER MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
XIROS LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 222 222
2020 210 210
2021 148 148
2022 95 95
2023 155 155
2024 83 83

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 338 338
Break 205 205
Fracture 67 67
Detachment of Device or Device Component 49 49
Mechanical Jam 34 34
Material Deformation 20 20
Material Twisted/Bent 20 20
Device-Device Incompatibility 17 17
Material Split, Cut or Torn 17 17
Migration 16 16
Defective Device 14 14
Entrapment of Device 14 14
Physical Resistance/Sticking 12 12
Use of Device Problem 11 11
Insufficient Information 11 11
Appropriate Term/Code Not Available 10 10
Device Dislodged or Dislocated 9 9
Patient Device Interaction Problem 9 9
Material Fragmentation 8 8
Failure to Power Up 8 8
Loose or Intermittent Connection 7 7
Activation Failure 7 7
Migration or Expulsion of Device 6 6
Difficult to Remove 6 6
Improper or Incorrect Procedure or Method 6 6
Device Slipped 5 5
Unintended Movement 5 5
Positioning Problem 5 5
Therapeutic or Diagnostic Output Failure 4 4
Manufacturing, Packaging or Shipping Problem 4 4
Output Problem 4 4
Failure to Advance 4 4
Unstable 4 4
Malposition of Device 3 3
Tear, Rip or Hole in Device Packaging 3 3
Product Quality Problem 3 3
Material Rupture 3 3
Material Separation 3 3
Material Frayed 3 3
Loosening of Implant Not Related to Bone-Ingrowth 3 3
Positioning Failure 2 2
Off-Label Use 2 2
Difficult to Insert 2 2
Delivered as Unsterile Product 2 2
Inadequacy of Device Shape and/or Size 2 2
Failure to Osseointegrate 2 2
Expiration Date Error 2 2
Separation Failure 2 2
Failure to Cut 2 2
Patient-Device Incompatibility 2 2
Device Displays Incorrect Message 2 2
Connection Problem 2 2
Material Protrusion/Extrusion 2 2
No Apparent Adverse Event 2 2
Scratched Material 1 1
Packaging Problem 1 1
Naturally Worn 1 1
Difficult to Advance 1 1
Sparking 1 1
Blocked Connection 1 1
Failure to Align 1 1
Smoking 1 1
Unraveled Material 1 1
Visual Prompts will not Clear 1 1
Device Damaged Prior to Use 1 1
Defective Component 1 1
Component Missing 1 1
Shipping Damage or Problem 1 1
Disconnection 1 1
No Display/Image 1 1
Display or Visual Feedback Problem 1 1
Electrical /Electronic Property Problem 1 1
Flaked 1 1
Contamination 1 1
Corroded 1 1
Image Display Error/Artifact 1 1
Nonstandard Device 1 1
Mechanical Problem 1 1
Separation Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 198 198
Unspecified Infection 90 90
Insufficient Information 82 82
Failure of Implant 63 63
No Consequences Or Impact To Patient 59 59
Non-union Bone Fracture 49 49
No Code Available 45 45
Injury 44 44
Swelling/ Edema 42 42
Pain 41 41
No Known Impact Or Consequence To Patient 35 35
Post Operative Wound Infection 33 33
Foreign Body In Patient 32 32
Implant Pain 31 31
Not Applicable 25 25
Tissue Damage 24 24
Discomfort 22 22
Bone Fracture(s) 17 17
No Patient Involvement 15 15
Cellulitis 14 14
Device Embedded In Tissue or Plaque 13 13
Inflammation 10 10
Loss of Range of Motion 10 10
Unspecified Tissue Injury 10 10
Swelling 9 9
Impaired Healing 8 8
Physical Asymmetry 8 8
Skin Inflammation/ Irritation 6 6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
Deformity/ Disfigurement 6 6
Nerve Damage 6 6
Bacterial Infection 6 6
Hypersensitivity/Allergic reaction 5 5
Joint Disorder 5 5
Osteolysis 5 5
No Information 5 5
Organ Dehiscence 5 5
Malunion of Bone 5 5
Unspecified Musculoskeletal problem 5 5
Patient Problem/Medical Problem 4 4
Fall 4 4
Arthritis 3 3
Neuropathy 3 3
Necrosis 3 3
Fracture, Arm 3 3
Hypoesthesia 2 2
Synovitis 2 2
Thrombosis 2 2
Limb Fracture 2 2
Joint Laxity 2 2
Sepsis 2 2
Perforation 2 2
Hematoma 2 2
Erythema 2 2
Edema 2 2
Erosion 2 2
Cyst(s) 2 2
Pulmonary Embolism 2 2
Adhesion(s) 2 2
Fluid Discharge 2 2
Muscle/Tendon Damage 1 1
Drug Resistant Bacterial Infection 1 1
Wound Dehiscence 1 1
Abscess 1 1
Purulent Discharge 1 1
Embolus 1 1
Fatigue 1 1
Fever 1 1
Foreign Body Reaction 1 1
Granuloma 1 1
Laceration(s) 1 1
Muscular Rigidity 1 1
Pleural Effusion 1 1
Joint Contracture 1 1
Paresthesia 1 1
Thromboembolism 1 1
Pseudoaneurysm 1 1
Weight Changes 1 1
Paraplegia 1 1
Needle Stick/Puncture 1 1
Urinary Retention 1 1
Hip Fracture 1 1
Rupture 1 1
Ulcer 1 1
Inadequate Pain Relief 1 1
Sweating 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
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