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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 1
AKROS MEDICAL
  SUBSTANTIALLY EQUIVALENT 3
ARTHREX INC.
  SUBSTANTIALLY EQUIVALENT 5
ARTHROSURFACE, INC
  SUBSTANTIALLY EQUIVALENT 1
CC-INSTRUMENTS INC
  SUBSTANTIALLY EQUIVALENT 1
CONMED CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
CORIN USA
  SUBSTANTIALLY EQUIVALENT 1
CYCLA ORTHOPEDICS LTD
  SUBSTANTIALLY EQUIVALENT 1
GM DOS REIS INDUSTRIA E COMERCIO LTDA
  SUBSTANTIALLY EQUIVALENT 1
IN2BONES USA, LLC
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MORTISE MEDICAL LLC
  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
TRIMED, INC.
  SUBSTANTIALLY EQUIVALENT 1
WRIGHT MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 1
XIROS LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 30 30
2018 47 47
2019 52 52
2020 81 81
2021 148 148
2022 85 85
2023 108 108
2024 67 67

Device Problems MDRs with this Device Problem Events in those MDRs
Break 233 233
Adverse Event Without Identified Device or Use Problem 153 153
Device-Device Incompatibility 28 28
Appropriate Term/Code Not Available 22 22
Device Dislodged or Dislocated 18 18
Migration 15 15
Patient Device Interaction Problem 15 15
Entrapment of Device 14 14
Detachment of Device or Device Component 13 13
Difficult to Advance 13 13
Device Slipped 12 12
Fracture 9 9
Insufficient Information 8 8
Material Split, Cut or Torn 8 8
Physical Resistance/Sticking 7 7
Material Separation 7 7
Migration or Expulsion of Device 5 5
Defective Device 5 5
Patient-Device Incompatibility 5 5
Failure to Advance 5 5
Material Twisted/Bent 5 5
Use of Device Problem 4 4
Difficult To Position 4 4
Difficult to Remove 3 3
Improper or Incorrect Procedure or Method 3 3
Device Markings/Labelling Problem 3 3
Device Operates Differently Than Expected 3 3
Expulsion 3 3
No Apparent Adverse Event 3 3
Activation, Positioning or Separation Problem 2 2
Activation Problem 2 2
Loosening of Implant Not Related to Bone-Ingrowth 2 2
Expiration Date Error 2 2
Material Integrity Problem 2 2
Material Protrusion/Extrusion 2 2
Output Problem 2 2
Positioning Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Component Missing 2 2
Material Fragmentation 2 2
Loose or Intermittent Connection 2 2
Mechanical Problem 1 1
Detachment Of Device Component 1 1
Use of Incorrect Control/Treatment Settings 1 1
Knotted 1 1
Material Rupture 1 1
Inadequacy of Device Shape and/or Size 1 1
Off-Label Use 1 1
Delivered as Unsterile Product 1 1
Unsealed Device Packaging 1 1
Failure to Align 1 1
Fitting Problem 1 1
Stretched 1 1
Unraveled Material 1 1
Unstable 1 1
Device Damaged by Another Device 1 1
Contamination /Decontamination Problem 1 1
Delivery System Failure 1 1
Misassembly by Users 1 1
Packaging Problem 1 1
Naturally Worn 1 1
Compatibility Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Deformation 1 1
Separation Problem 1 1
Device Handling Problem 1 1
Noise, Audible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 194 194
Insufficient Information 80 80
Pain 68 68
No Code Available 66 66
Failure of Implant 41 41
Unspecified Infection 30 30
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 29 29
Foreign Body In Patient 28 28
Non-union Bone Fracture 25 25
No Known Impact Or Consequence To Patient 23 23
No Consequences Or Impact To Patient 21 21
Bone Fracture(s) 12 12
Injury 10 10
No Information 10 10
Joint Dislocation 8 8
Necrosis 7 7
Hypersensitivity/Allergic reaction 7 7
Swelling 6 6
Impaired Healing 6 6
Device Embedded In Tissue or Plaque 6 6
Post Operative Wound Infection 5 5
Osteolysis 5 5
Loss of Range of Motion 5 5
Implant Pain 4 4
Physical Asymmetry 4 4
Limited Mobility Of The Implanted Joint 3 3
Discomfort 3 3
Reaction 3 3
Foreign Body Reaction 3 3
Bacterial Infection 3 3
Fatigue 2 2
Wound Dehiscence 2 2
Tissue Damage 2 2
Nerve Damage 2 2
Inflammation 2 2
Damage to Ligament(s) 2 2
Anxiety 2 2
Distress 2 2
Arthralgia 2 2
No Patient Involvement 2 2
Not Applicable 2 2
Swelling/ Edema 2 2
Limb Fracture 1 1
Patient Problem/Medical Problem 1 1
Osteopenia/ Osteoporosis 1 1
Alteration In Body Temperature 1 1
Complaint, Ill-Defined 1 1
Numbness 1 1
Sweating 1 1
Needle Stick/Puncture 1 1
Palpitations 1 1
Sleep Dysfunction 1 1
Weight Changes 1 1
Muscular Rigidity 1 1
Pleural Effusion 1 1
Tinnitus 1 1
Rash 1 1
Scar Tissue 1 1
Increased Sensitivity 1 1
Abscess 1 1
Arthritis 1 1
Autoimmune Disorder 1 1
Headache 1 1
Erosion 1 1
Bradycardia 1 1
Cyst(s) 1 1
Purulent Discharge 1 1
Edema 1 1
Erythema 1 1
Fall 1 1

Recalls
Manufacturer Recall Class Date Posted
1 TriMed Inc. II Feb-07-2023
2 Zimmer Biomet, Inc. II Nov-07-2019
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