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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
2018 400 400
2019 281 281
2020 245 245
2021 228 228
2022 182 182
2023 48 48

Device Problems MDRs with this Device Problem Events in those MDRs
Break 859 859
Fracture 80 80
Detachment of Device or Device Component 77 77
Entrapment of Device 69 69
Difficult to Remove 61 61
Insufficient Information 49 49
Adverse Event Without Identified Device or Use Problem 46 46
Detachment Of Device Component 41 41
Appropriate Term/Code Not Available 34 34
Material Fragmentation 28 28
Device Operates Differently Than Expected 25 25
Crack 24 24
Component Missing 21 21
Device Damaged by Another Device 16 16
Material Separation 14 14
Material Twisted/Bent 14 14
Mechanical Jam 13 13
Device Fell 13 13
Mechanical Problem 13 13
Dull, Blunt 12 12
Physical Resistance/Sticking 12 12
Connection Problem 10 10
Loose or Intermittent Connection 10 10
Material Split, Cut or Torn 9 9
Failure to Disinfect 8 8
Defective Device 7 7
Device Or Device Fragments Location Unknown 7 7
Misfire 7 7
Defective Component 6 6
Device-Device Incompatibility 6 6
Naturally Worn 6 6
Material Deformation 6 6
Patient Device Interaction Problem 5 5
Activation, Positioning or Separation Problem 5 5
Failure to Fire 5 5
Bent 5 5
Device Slipped 5 5
Corroded 4 4
Flaked 4 4
Difficult to Insert 4 4
Failure to Cut 4 4
Device Dislodged or Dislocated 4 4
Output Problem 4 4
Material Integrity Problem 3 3
Migration 3 3
Separation Problem 3 3
Failure to Advance 3 3
Use of Device Problem 3 3
Sticking 3 3
Particulates 3 3
Peeled/Delaminated 2 2
Migration or Expulsion of Device 2 2
Misconnection 2 2
Delivered as Unsterile Product 2 2
Unexpected Therapeutic Results 2 2
Device Inoperable 2 2
Product Quality Problem 2 2
Unstable 2 2
Disconnection 2 2
Disassembly 2 2
Component Falling 2 2
Improper or Incorrect Procedure or Method 2 2
Device Damaged Prior to Use 2 2
Failure to Align 2 2
Difficult or Delayed Activation 2 2
Device Markings/Labelling Problem 2 2
Difficult to Advance 2 2
Difficult to Open or Close 2 2
Contamination /Decontamination Problem 2 2
Firing Problem 2 2
Loosening of Implant Not Related to Bone-Ingrowth 2 2
Noise, Audible 2 2
Device Contamination with Chemical or Other Material 2 2
Device Contaminated During Manufacture or Shipping 2 2
Packaging Problem 2 2
Physical Property Issue 2 2
Power Problem 1 1
Protective Measures Problem 1 1
Scratched Material 1 1
Therapeutic or Diagnostic Output Failure 1 1
Torn Material 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Protrusion/Extrusion 1 1
Difficult or Delayed Separation 1 1
Missing Information 1 1
Incomplete or Inadequate Connection 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Malposition of Device 1 1
Patient-Device Incompatibility 1 1
Application Program Problem 1 1
Biocompatibility 1 1
Deformation Due to Compressive Stress 1 1
Failure to Disconnect 1 1
Structural Problem 1 1
Residue After Decontamination 1 1
Insufficient Flow or Under Infusion 1 1
Fitting Problem 1 1
Inability to Auto-Fill 1 1
Material Discolored 1 1
No Display/Image 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 284 284
No Clinical Signs, Symptoms or Conditions 200 200
No Consequences Or Impact To Patient 198 198
Device Embedded In Tissue or Plaque 163 163
Foreign Body In Patient 160 160
Insufficient Information 106 106
No Information 80 80
Injury 75 75
No Patient Involvement 42 42
No Code Available 18 18
Failure of Implant 16 16
Unspecified Infection 13 13
Pain 13 13
Bone Fracture(s) 12 12
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 12 12
Tissue Damage 6 6
Not Applicable 5 5
Post Operative Wound Infection 4 4
Spinal Column Injury 4 4
Laceration(s) 3 3
Discomfort 3 3
Metal Related Pathology 3 3
Unspecified Tissue Injury 3 3
Swelling/ Edema 3 3
Joint Laxity 2 2
Patient Problem/Medical Problem 2 2
Hemorrhage/Bleeding 2 2
Purulent Discharge 2 2
Edema 1 1
Endophthalmitis 1 1
Hematoma 1 1
Wound Dehiscence 1 1
Vessel Or Plaque, Device Embedded In 1 1
Abrasion 1 1
Bacterial Infection 1 1
Exposure to Body Fluids 1 1
Bruise/Contusion 1 1
Muscular Rigidity 1 1
Inflammation 1 1
Synovitis 1 1
Perforation 1 1
Loss of Range of Motion 1 1
Complaint, Ill-Defined 1 1
Brain Injury 1 1
Ulcer 1 1
Pressure Sores 1 1
Anxiety 1 1
Burn, Thermal 1 1
Limited Mobility Of The Implanted Joint 1 1
Hip Fracture 1 1
Hypoesthesia 1 1
Arthralgia 1 1
Joint Dislocation 1 1
Impaired Healing 1 1
Increased Appetite 1 1
Subluxation 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
5 Medtronic Sofamor Danek USA Inc II Feb-09-2018
6 Smith & Nephew, Inc. II Jan-24-2018
7 Trilliant Surgical Ltd. II Jul-02-2018
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