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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 4
ARTHROSURFACE, 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
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 68 68

Device Problems MDRs with this Device Problem Events in those MDRs
Break 139 139
Adverse Event Without Identified Device or Use Problem 137 137
Device-Device Incompatibility 23 23
Appropriate Term/Code Not Available 21 21
Difficult to Advance 12 12
Entrapment of Device 10 10
Device Slipped 9 9
Migration 9 9
Fracture 9 9
Insufficient Information 7 7
Device Dislodged or Dislocated 6 6
Migration or Expulsion of Device 5 5
Patient-Device Incompatibility 5 5
Patient Device Interaction Problem 5 5
Material Twisted/Bent 4 4
Material Separation 4 4
Difficult To Position 4 4
Detachment of Device or Device Component 4 4
Defective Device 3 3
No Apparent Adverse Event 3 3
Device Markings/Labelling Problem 3 3
Difficult to Remove 3 3
Device Operates Differently Than Expected 3 3
Expulsion 3 3
Improper or Incorrect Procedure or Method 3 3
Failure to Advance 2 2
Material Protrusion/Extrusion 2 2
Material Fragmentation 2 2
Positioning Problem 2 2
Loose or Intermittent Connection 2 2
Activation Problem 2 2
Component Missing 2 2
Therapeutic or Diagnostic Output Failure 2 2
Output Problem 2 2
Activation, Positioning or SeparationProblem 2 2
Naturally Worn 1 1
Packaging Problem 1 1
Failure to Align 1 1
Delivery System Failure 1 1
Stretched 1 1
Mechanical Problem 1 1
Separation Problem 1 1
Noise, Audible 1 1
Material Split, Cut or Torn 1 1
Delivered as Unsterile Product 1 1
Material Rupture 1 1
Unraveled Material 1 1
Off-Label Use 1 1
Use of Incorrect Control Settings 1 1
Expiration Date Error 1 1
Misassembly by Users 1 1
Device Handling Problem 1 1
Detachment Of Device Component 1 1
Knotted 1 1
Unstable 1 1
Physical Resistance/Sticking 1 1
Material Deformation 1 1
Material Integrity Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 111 111
No Code Available 66 66
Pain 63 63
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 29 29
Unspecified Infection 26 26
Failure of Implant 23 23
Insufficient Information 23 23
No Known Impact Or Consequence To Patient 23 23
No Consequences Or Impact To Patient 21 21
Non-union Bone Fracture 20 20
Foreign Body In Patient 17 17
No Information 10 10
Injury 10 10
Bone Fracture(s) 10 10
Necrosis 6 6
Joint Dislocation 6 6
Swelling 6 6
Device Embedded In Tissue or Plaque 6 6
Osteolysis 5 5
Impaired Healing 5 5
Hypersensitivity/Allergic reaction 4 4
Post Operative Wound Infection 4 4
Limited Mobility Of The Implanted Joint 3 3
Physical Asymmetry 3 3
Bacterial Infection 3 3
Reaction 3 3
Loss of Range of Motion 3 3
Anxiety 2 2
Discomfort 2 2
Fatigue 2 2
Nerve Damage 2 2
Inflammation 2 2
Swelling/ Edema 2 2
Not Applicable 2 2
Tissue Damage 2 2
Arthralgia 2 2
No Patient Involvement 2 2
Osteopenia/ Osteoporosis 1 1
Needle Stick/Puncture 1 1
Palpitations 1 1
Sleep Dysfunction 1 1
Weight Changes 1 1
Alteration In Body Temperature 1 1
Patient Problem/Medical Problem 1 1
Muscular Rigidity 1 1
Headache 1 1
Foreign Body Reaction 1 1
Abscess 1 1
Arthritis 1 1
Autoimmune Disorder 1 1
Bradycardia 1 1
Cyst(s) 1 1
Purulent Discharge 1 1
Edema 1 1
Erythema 1 1
Fall 1 1
Complaint, Ill-Defined 1 1
Numbness 1 1
Sweating 1 1
Rash 1 1
Scar Tissue 1 1
Increased Sensitivity 1 1
Tinnitus 1 1
Pleural Effusion 1 1

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