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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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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 210 210
2024 79 79

Device Problems MDRs with this Device Problem Events in those MDRs
Break 777 777
Fracture 68 68
Detachment of Device or Device Component 64 64
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
Physical Resistance/Sticking 21 21
Component Missing 20 20
Material Twisted/Bent 19 19
Appropriate Term/Code Not Available 17 17
Material Separation 15 15
Dull, Blunt 14 14
Mechanical Jam 13 13
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
Patient Device Interaction Problem 6 6
Connection Problem 6 6
Contamination /Decontamination Problem 5 5
Failure to Cut 5 5
Defective Device 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
Use of Device Problem 5 5
Flaked 4 4
Corroded 4 4
Output Problem 4 4
Device-Device Incompatibility 3 3
Misfire 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
Incorrect Measurement 2 2
Misconnection 2 2
Delivered as Unsterile Product 2 2
Failure to Advance 2 2
Device Markings/Labelling Problem 2 2
Difficult to Advance 2 2
Difficult to Open or Close 2 2
Device Contaminated During Manufacture or Shipping 2 2
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
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
Unintended Collision 1 1
Overheating of Device 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 321 321
Foreign Body In Patient 175 175
Insufficient Information 164 164
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 14 14
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 13 13
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 Applied Medical Resources Corp II Mar-27-2024
2 Arthrex, Inc. II Dec-08-2022
3 ENDO Pharmaceuticals Solutions, Inc. II Dec-30-2022
4 FlexDex Inc. II Jan-27-2022
5 MEDLINE INDUSTRIES, LP - Northfield II Mar-29-2024
6 MEDLINE INDUSTRIES, LP - Northfield II Feb-06-2023
7 Technicality Inc. II Apr-02-2024
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