Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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
2018 400 400
2019 281 281
2020 244 244
2021 227 227
2022 182 182
2023 162 162

Device Problems MDRs with this Device Problem Events in those MDRs
Break 931 931
Detachment of Device or Device Component 84 84
Fracture 81 81
Entrapment of Device 69 69
Difficult to Remove 62 62
Adverse Event Without Identified Device or Use Problem 54 54
Insufficient Information 49 49
Detachment Of Device Component 41 41
Appropriate Term/Code Not Available 36 36
Material Fragmentation 29 29
Crack 25 25
Device Operates Differently Than Expected 25 25
Component Missing 21 21
Dull, Blunt 16 16
Device Damaged by Another Device 16 16
Material Separation 15 15
Mechanical Problem 15 15
Material Twisted/Bent 15 15
Physical Resistance/Sticking 14 14
Device Fell 13 13
Mechanical Jam 13 13
Loose or Intermittent Connection 10 10
Connection Problem 10 10
Defective Device 9 9
Material Split, Cut or Torn 9 9
Activation, Positioning or Separation Problem 8 8
Failure to Disinfect 8 8
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
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
Use of Device Problem 4 4
Device Dislodged or Dislocated 4 4
Output Problem 4 4
Material Integrity Problem 3 3
Separation Problem 3 3
Migration 3 3
Failure to Advance 3 3
Sticking 3 3
Particulates 3 3
Delivered as Unsterile Product 3 3
Peeled/Delaminated 2 2
Migration or Expulsion of Device 2 2
Unexpected Therapeutic Results 2 2
Device Inoperable 2 2
Misconnection 2 2
Product Quality Problem 2 2
Disconnection 2 2
Disassembly 2 2
Component Falling 2 2
Difficult or Delayed Activation 2 2
Contamination /Decontamination Problem 2 2
Difficult to Advance 2 2
Difficult to Open or Close 2 2
Device Markings/Labelling Problem 2 2
Improper or Incorrect Procedure or Method 2 2
Unstable 2 2
Device Damaged Prior to Use 2 2
Failure to Align 2 2
Loosening of Implant Not Related to Bone-Ingrowth 2 2
Noise, Audible 2 2
Firing Problem 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
Unintended Movement 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Protrusion/Extrusion 1 1
Incomplete or Inadequate Connection 1 1
Difficult or Delayed Separation 1 1
Missing Information 1 1
Failure to Disconnect 1 1
Structural Problem 1 1
Residue After Decontamination 1 1
Inadequacy of Device Shape and/or Size 1 1
Insufficient Flow or Under Infusion 1 1
Fitting Problem 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Malposition of Device 1 1
Patient-Device Incompatibility 1 1
Application Program Problem 1 1
Deformation Due to Compressive Stress 1 1
Inability to Auto-Fill 1 1
Material Discolored 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 283 283
No Clinical Signs, Symptoms or Conditions 247 247
No Consequences Or Impact To Patient 198 198
Foreign Body In Patient 183 183
Device Embedded In Tissue or Plaque 163 163
Insufficient Information 138 138
No Information 80 80
Injury 75 75
No Patient Involvement 42 42
Failure of Implant 20 20
No Code Available 18 18
Unspecified Infection 13 13
Pain 13 13
Bone Fracture(s) 12 12
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 12 12
Perforation 7 7
Tissue Damage 6 6
Not Applicable 5 5
Pericardial Effusion 4 4
Post Operative Wound Infection 4 4
Spinal Column Injury 4 4
Low Blood Pressure/ Hypotension 4 4
Laceration(s) 3 3
Cardiac Tamponade 3 3
Unspecified Tissue Injury 3 3
Swelling/ Edema 3 3
Internal Organ Perforation 2 2
Discomfort 2 2
Patient Problem/Medical Problem 2 2
Heart Block 2 2
Joint Laxity 2 2
Metal Related Pathology 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
Inflammation 1 1
Loss of Range of Motion 1 1
Sepsis 1 1
Cardiogenic Shock 1 1
Ulcer 1 1
Pressure Sores 1 1
Hip Fracture 1 1
Hypoesthesia 1 1
Arthralgia 1 1
Joint Dislocation 1 1
Impaired Healing 1 1
Obstruction/Occlusion 1 1
Muscular Rigidity 1 1
Synovitis 1 1
Perforation of Vessels 1 1
Brain Injury 1 1
Subluxation 1 1
Limited Mobility Of The Implanted Joint 1 1
Complaint, Ill-Defined 1 1
Burn, Thermal 1 1
Increased Appetite 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
-
-