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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device washer, bolt nut
Product CodeHTN
Regulation Number 888.3030
Device Class 2


Premarket Reviews
ManufacturerDecision
ACUMED LLC
  SUBSTANTIALLY EQUIVALENT 3
AKROS MEDICAL
  SUBSTANTIALLY EQUIVALENT 3
ARTHREX INC.
  SUBSTANTIALLY EQUIVALENT 5
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 4
ARTHROSURFACE, INC
  SUBSTANTIALLY EQUIVALENT 1
ARTHROSURFACE, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOMET MANUFACTURING CORP.
  SUBSTANTIALLY EQUIVALENT 1
BIOPRO, INC.
  SUBSTANTIALLY EQUIVALENT 1
CC-INSTRUMENTS INC
  SUBSTANTIALLY EQUIVALENT 1
CONMED CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
CORACOID SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
CORIN USA
  SUBSTANTIALLY EQUIVALENT 1
CYCLA ORTHOPEDICS LTD
  SUBSTANTIALLY EQUIVALENT 1
DALLEN MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 5
GLOBUS MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 1
GM DOS REIS INDUSTRIA E COMERCIO LTDA
  SUBSTANTIALLY EQUIVALENT 1
IN2BONES USA, LLC
  SUBSTANTIALLY EQUIVALENT 1
INSTRATEK, INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDLINE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDSHAPE, INC
  SUBSTANTIALLY EQUIVALENT 1
MORTISE MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
ORTHOHELIX SURGICAL DESIGNS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ORTHOPAEDIC IMPLANT COMPANY
  SUBSTANTIALLY EQUIVALENT 1
PANTHER ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 1
SMITH AND NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 1
SURGICRAFT LTD.
  SUBSTANTIALLY EQUIVALENT 1
TRIMED, INC.
  SUBSTANTIALLY EQUIVALENT 1
WRIGHT MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 1
XIROS LTD
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 33 33
2015 34 34
2016 43 43
2017 30 30
2018 47 47
2019 52 52
2020 81 81
2021 148 148
2022 85 85
2023 108 108
2024 135 135

Device Problems MDRs with this Device Problem Events in those MDRs
Break 289 289
Adverse Event Without Identified Device or Use Problem 180 180
Device-Device Incompatibility 35 35
Appropriate Term/Code Not Available 27 27
Device Dislodged or Dislocated 21 21
Detachment of Device or Device Component 20 20
Migration 19 19
Difficult to Advance 17 17
Device Slipped 17 17
Patient Device Interaction Problem 16 16
Material Split, Cut or Torn 15 15
Entrapment of Device 15 15
Fracture 13 13
Device Operates Differently Than Expected 11 11
Defective Device 11 11
Insufficient Information 11 11
Use of Device Problem 9 9
Material Separation 9 9
Migration or Expulsion of Device 8 8
Physical Resistance/Sticking 8 8
Material Frayed 6 6
Detachment Of Device Component 6 6
Patient-Device Incompatibility 6 6
Material Twisted/Bent 6 6
Difficult To Position 5 5
Difficult to Remove 5 5
Improper or Incorrect Procedure or Method 5 5
Failure to Advance 5 5
Material Fragmentation 4 4
Loosening of Implant Not Related to Bone-Ingrowth 4 4
Loose or Intermittent Connection 3 3
Expiration Date Error 3 3
Material Integrity Problem 3 3
Positioning Problem 3 3
No Apparent Adverse Event 3 3
Unintended Movement 3 3
Device Markings/Labelling Problem 3 3
Unstable 3 3
Expulsion 3 3
Manufacturing, Packaging or Shipping Problem 2 2
Failure to Align 2 2
Therapeutic or Diagnostic Output Failure 2 2
Activation, Positioning or Separation Problem 2 2
Output Problem 2 2
Material Protrusion/Extrusion 2 2
Fitting Problem 2 2
Component Missing 2 2
Material Rupture 2 2
Activation Problem 2 2
Separation Problem 1 1
Component Misassembled 1 1
Inadequacy of Device Shape and/or Size 1 1
Metal Shedding Debris 1 1
Stretched 1 1
Unraveled Material 1 1
Cut In Material 1 1
Structural Problem 1 1
Separation Failure 1 1
Failure to Form Staple 1 1
Mechanical Problem 1 1
Knotted 1 1
Off-Label Use 1 1
Delivered as Unsterile Product 1 1
Unsealed Device Packaging 1 1
Failure To Adhere Or Bond 1 1
Bent 1 1
Contamination 1 1
Use of Incorrect Control/Treatment Settings 1 1
Mechanical Jam 1 1
Naturally Worn 1 1
Packaging Problem 1 1
Power Problem 1 1
Device Handling Problem 1 1
Noise, Audible 1 1
Torn Material 1 1
Misassembly by Users 1 1
Contamination /Decontamination Problem 1 1
Delivery System Failure 1 1
Material Deformation 1 1
Compatibility Problem 1 1
Device Damaged by Another Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 229 229
Insufficient Information 107 107
No Code Available 102 102
Pain 87 87
Failure of Implant 54 54
Unspecified Infection 40 40
No Known Impact Or Consequence To Patient 40 40
Foreign Body In Patient 31 31
Non-union Bone Fracture 31 31
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 29 29
No Consequences Or Impact To Patient 21 21
Impaired Healing 16 16
Bone Fracture(s) 16 16
No Information 13 13
Joint Dislocation 11 11
Device Embedded In Tissue or Plaque 11 11
Injury 10 10
Necrosis 10 10
Hypersensitivity/Allergic reaction 9 9
Swelling 8 8
Reaction 8 8
Discomfort 8 8
Loss of Range of Motion 7 7
Tissue Damage 5 5
Osteolysis 5 5
Post Operative Wound Infection 5 5
Limited Mobility Of The Implanted Joint 4 4
Implant Pain 4 4
Physical Asymmetry 4 4
Irritation 4 4
Inflammation 3 3
Fall 3 3
Foreign Body Reaction 3 3
Bacterial Infection 3 3
Wound Dehiscence 2 2
Abscess 2 2
Arthritis 2 2
Erythema 2 2
Fatigue 2 2
Hematoma 2 2
Nerve Damage 2 2
Damage to Ligament(s) 2 2
Rash 2 2
Swelling/ Edema 2 2
Limb Fracture 2 2
Not Applicable 2 2
No Patient Involvement 2 2
Arthralgia 2 2
Anxiety 2 2
Distress 2 2
Complaint, Ill-Defined 1 1
Ulceration 1 1
Viral Infection 1 1
Sinus Perforation 1 1
Deformity/ Disfigurement 1 1
Numbness 1 1
Sweating 1 1
Osteopenia/ Osteoporosis 1 1
Alteration In Body Temperature 1 1
Fluid Discharge 1 1
Needle Stick/Puncture 1 1
Palpitations 1 1
Sleep Dysfunction 1 1
Weight Changes 1 1
Patient Problem/Medical Problem 1 1
Staphylococcus Aureus 1 1
Scar Tissue 1 1
Increased Sensitivity 1 1
Tinnitus 1 1
Paresis 1 1
Pleural Effusion 1 1
Muscle Weakness 1 1
Muscular Rigidity 1 1
Headache 1 1
Autoimmune Disorder 1 1
Ossification 1 1
Erosion 1 1
Bradycardia 1 1
Cyst(s) 1 1
Purulent Discharge 1 1
Edema 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Arthrex, Inc. III Sep-30-2016
2 Synthes USA HQ, Inc. II Nov-26-2013
3 TriMed Inc. II Feb-07-2023
4 Zimmer Biomet, Inc. II Nov-07-2019
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