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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
Regulation Description Single/multiple component metallic bone fixation appliances and accessories.
Product CodeHTN
Regulation Number 888.3030
Device Class 2


Premarket Reviews
ManufacturerDecision
AKROS MEDICAL
  SUBSTANTIALLY EQUIVALENT 3
ARTHREX INC.
  SUBSTANTIALLY EQUIVALENT 1
ARTHROSURFACE, 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
GM DOS REIS INDUSTRIA E COMERCIO LTDA
  SUBSTANTIALLY EQUIVALENT 1
MORTISE MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
PANTHER ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 1
SMITH AND NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 1
WRIGHT MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 1
XIROS LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 43 43
2017 30 30
2018 47 47
2019 52 52
2020 81 81
2021 107 107

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 117 117
Break 106 106
Appropriate Term/Code Not Available 21 21
Device-Device Incompatibility 15 15
Difficult to Advance 11 11
Fracture 10 10
Migration or Expulsion of Device 7 7
Device Slipped 7 7
Insufficient Information 7 7
Device Operates Differently Than Expected 6 6
Device Dislodged or Dislocated 6 6
Patient-Device Incompatibility 6 6
Improper or Incorrect Procedure or Method 5 5
Difficult To Position 5 5
Entrapment of Device 5 5
Detachment Of Device Component 4 4
Material Separation 4 4
Detachment of Device or Device Component 4 4
Material Twisted/Bent 4 4
No Apparent Adverse Event 3 3
Migration 3 3
Expulsion 3 3
Material Fragmentation 3 3
Difficult to Remove 2 2
Loose or Intermittent Connection 2 2
Material Protrusion/Extrusion 2 2
Activation, Positioning or SeparationProblem 2 2
Component Missing 2 2
Failure to Align 2 2
Failure to Advance 2 2
Defective Device 2 2
Positioning Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Unintended Movement 2 2
Misassembly by Users 1 1
Power Problem 1 1
Naturally Worn 1 1
Packaging Problem 1 1
Physical Resistance/Sticking 1 1
Activation Problem 1 1
Separation Problem 1 1
Noise, Audible 1 1
Fitting Problem 1 1
Delivery System Failure 1 1
Device Markings/Labelling Problem 1 1
Mechanical Problem 1 1
Delivered as Unsterile Product 1 1
Material Rupture 1 1
Stretched 1 1
Unraveled Material 1 1
Material Frayed 1 1
Knotted 1 1
Failure To Adhere Or Bond 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 82 82
No Clinical Signs, Symptoms or Conditions 68 68
Pain 59 59
Failure of Implant 26 26
No Known Impact Or Consequence To Patient 25 25
No Consequences Or Impact To Patient 21 21
Unspecified Infection 20 20
Non-union Bone Fracture 17 17
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 13 13
No Information 12 12
Impaired Healing 11 11
Bone Fracture(s) 11 11
Insufficient Information 11 11
Injury 10 10
Foreign Body In Patient 10 10
Device Embedded In Tissue or Plaque 8 8
Necrosis 7 7
Swelling 6 6
Reaction 5 5
Loss of Range of Motion 4 4
Hypersensitivity/Allergic reaction 4 4
Joint Dislocation 3 3
Limited Mobility Of The Implanted Joint 3 3
Bacterial Infection 3 3
Tissue Damage 3 3
Anxiety 2 2
Discomfort 2 2
No Patient Involvement 2 2
Not Applicable 2 2
Arthralgia 2 2
Swelling/ Edema 2 2
Fatigue 2 2
Inflammation 2 2
Irritation 2 2
Rash 2 2
Increased Sensitivity 1 1
Ulceration 1 1
Sinus Perforation 1 1
Deformity/ Disfigurement 1 1
Physical Asymmetry 1 1
Abscess 1 1
Arthritis 1 1
Autoimmune Disorder 1 1
Cyst(s) 1 1
Erythema 1 1
Fall 1 1
Osteolysis 1 1
Numbness 1 1
Sweating 1 1
Palpitations 1 1
Sleep Dysfunction 1 1
Osteopenia/ Osteoporosis 1 1
Fluid Discharge 1 1
Nerve Damage 1 1
Post Operative Wound Infection 1 1
Weight Changes 1 1
Patient Problem/Medical Problem 1 1
Ossification 1 1
Alteration In Body Temperature 1 1
Complaint, Ill-Defined 1 1
Pleural Effusion 1 1
Scar Tissue 1 1
Tinnitus 1 1
Bradycardia 1 1
Purulent Discharge 1 1
Edema 1 1
Foreign Body Reaction 1 1
Headache 1 1
Muscular Rigidity 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Arthrex, Inc. III Sep-30-2016
2 Zimmer Biomet, Inc. II Nov-07-2019
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