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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device instrument, manual, surgical, general use
Product CodeMDM
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2019 281 281
2020 244 244
2021 227 227
2022 182 182
2023 209 209
2024 31 31

Device Problems MDRs with this Device Problem Events in those MDRs
Break 744 744
Fracture 66 66
Detachment of Device or Device Component 63 63
Entrapment of Device 57 57
Difficult to Remove 57 57
Adverse Event Without Identified Device or Use Problem 51 51
Insufficient Information 31 31
Material Fragmentation 26 26
Component Missing 20 20
Physical Resistance/Sticking 18 18
Appropriate Term/Code Not Available 17 17
Material Twisted/Bent 17 17
Material Separation 15 15
Mechanical Jam 13 13
Dull, Blunt 12 12
Mechanical Problem 12 12
Crack 9 9
Device Fell 9 9
Activation, Positioning or Separation Problem 8 8
Failure to Disinfect 8 8
Loose or Intermittent Connection 7 7
Material Split, Cut or Torn 7 7
Connection Problem 6 6
Contamination /Decontamination Problem 5 5
Defective Component 5 5
Naturally Worn 5 5
Material Deformation 5 5
Device Damaged by Another Device 5 5
Device Dislodged or Dislocated 5 5
Device Slipped 5 5
Patient Device Interaction Problem 5 5
Flaked 4 4
Use of Device Problem 4 4
Corroded 4 4
Output Problem 4 4
Failure to Cut 4 4
Defective Device 4 4
Misfire 3 3
Device-Device Incompatibility 3 3
Difficult to Insert 3 3
Device Damaged Prior to Use 3 3
Migration 3 3
Separation Problem 3 3
Firing Problem 2 2
Scratched Material 2 2
Loosening of Implant Not Related to Bone-Ingrowth 2 2
Unstable 2 2
Unexpected Therapeutic Results 2 2
Improper or Incorrect Procedure or Method 2 2
Product Quality Problem 2 2
Particulates 2 2
Misconnection 2 2
Delivered as Unsterile Product 2 2
Difficult to Advance 2 2
Difficult to Open or Close 2 2
Device Contaminated During Manufacture or Shipping 2 2
Failure to Advance 2 2
Device Markings/Labelling Problem 2 2
Failure to Fire 1 1
Malposition of Device 1 1
Patient-Device Incompatibility 1 1
Application Program Problem 1 1
Deformation Due to Compressive Stress 1 1
Failure to Disconnect 1 1
Difficult or Delayed Activation 1 1
Failure to Align 1 1
Residue After Decontamination 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Device Contamination with Chemical or Other Material 1 1
Packaging Problem 1 1
Power Problem 1 1
Material Integrity Problem 1 1
Material Protrusion/Extrusion 1 1
Unintended Collision 1 1
Overheating of Device 1 1
Incorrect Measurement 1 1
Material Discolored 1 1
Disconnection 1 1
No Display/Image 1 1
Display or Visual Feedback Problem 1 1
Material Erosion 1 1
Fire 1 1
Material Puncture/Hole 1 1
Problem with Sterilization 1 1
Inadequacy of Device Shape and/or Size 1 1
Insufficient Flow or Under Infusion 1 1
Fitting Problem 1 1
Unraveled Material 1 1
Therapeutic or Diagnostic Output Failure 1 1
Unintended Movement 1 1
Incomplete or Inadequate Connection 1 1
Difficult or Delayed Separation 1 1
Missing Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 289 289
Foreign Body In Patient 170 170
Insufficient Information 154 154
No Known Impact Or Consequence To Patient 128 128
Device Embedded In Tissue or Plaque 124 124
No Consequences Or Impact To Patient 116 116
Injury 65 65
No Patient Involvement 39 39
Failure of Implant 19 19
No Information 18 18
Unspecified Infection 13 13
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 12 12
No Code Available 11 11
Pain 11 11
Bone Fracture(s) 11 11
Perforation 6 6
Low Blood Pressure/ Hypotension 4 4
Tissue Damage 4 4
Pericardial Effusion 4 4
Unspecified Tissue Injury 3 3
Post Operative Wound Infection 3 3
Swelling/ Edema 3 3
Cardiac Tamponade 3 3
Laceration(s) 2 2
Discomfort 2 2
Hemorrhage/Bleeding 2 2
Purulent Discharge 2 2
Internal Organ Perforation 2 2
Not Applicable 2 2
Joint Laxity 2 2
Metal Related Pathology 2 2
Heart Block 2 2
Subluxation 1 1
Increased Appetite 1 1
Burn, Thermal 1 1
Edema 1 1
Hematoma 1 1
Wound Dehiscence 1 1
Abrasion 1 1
Bacterial Infection 1 1
Exposure to Body Fluids 1 1
Bruise/Contusion 1 1
Inflammation 1 1
Loss of Range of Motion 1 1
Sepsis 1 1
Spinal Column Injury 1 1
Synovitis 1 1
Complaint, Ill-Defined 1 1
Brain Injury 1 1
Hip Fracture 1 1
Hypoesthesia 1 1
Arthralgia 1 1
Joint Dislocation 1 1
Impaired Healing 1 1
Obstruction/Occlusion 1 1
Damage to Ligament(s) 1 1
Muscular Rigidity 1 1
Perforation of Vessels 1 1
Cardiogenic Shock 1 1
Ulcer 1 1
Pressure Sores 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Arthrex, Inc. II Dec-08-2022
2 ENDO Pharmaceuticals Solutions, Inc. II Dec-30-2022
3 FlexDex Inc. II Jan-27-2022
4 MEDLINE INDUSTRIES, LP - Northfield II Feb-06-2023
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