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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
Regulation Description Manual surgical instrument for general use.
Product CodeMDM
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2016 316 316
2017 186 186
2018 400 400
2019 281 281
2020 247 247
2021 131 131

Device Problems MDRs with this Device Problem Events in those MDRs
Break 809 809
Fracture 186 186
Detachment Of Device Component 121 121
Detachment of Device or Device Component 69 69
Insufficient Information 53 53
Difficult to Remove 50 50
Component Missing 49 49
Adverse Event Without Identified Device or Use Problem 47 47
Entrapment of Device 42 42
Material Fragmentation 40 40
Device Or Device Fragments Location Unknown 37 37
Device Operates Differently Than Expected 34 34
Crack 34 34
Appropriate Term/Code Not Available 30 30
Torn Material 18 18
Device Damaged by Another Device 16 16
Connection Problem 15 15
Device-Device Incompatibility 14 14
Material Separation 14 14
Split 13 13
Material Deformation 13 13
Device Fell 12 12
Failure to Advance 12 12
Material Twisted/Bent 12 12
Corroded 11 11
Component Falling 10 10
Bent 10 10
Mechanical Problem 9 9
Misfire 9 9
Dull, Blunt 9 9
Loose or Intermittent Connection 9 9
Failure to Fire 9 9
Failure to Disinfect 8 8
Mechanical Jam 8 8
Naturally Worn 7 7
Device Dislodged or Dislocated 7 7
Metal Shedding Debris 7 7
Material Integrity Problem 7 7
Physical Resistance/Sticking 7 7
Sticking 7 7
Defective Component 7 7
Device Contamination with Body Fluid 6 6
Disassembly 6 6
Device Slipped 6 6
Material Split, Cut or Torn 5 5
Defective Device 5 5
Noise, Audible 4 4
Separation Failure 4 4
Failure to Cut 4 4
Melted 4 4
Migration or Expulsion of Device 4 4
Device Inoperable 4 4
Flaked 4 4
Difficult to Insert 4 4
Unraveled Material 3 3
Improper or Incorrect Procedure or Method 3 3
Inadequacy of Device Shape and/or Size 3 3
Migration 3 3
Device Reprocessing Problem 3 3
Failure to Align 3 3
Difficult to Open or Close 3 3
Packaging Problem 3 3
Physical Property Issue 2 2
Activation, Positioning or SeparationProblem 2 2
Device Packaging Compromised 2 2
Material Protrusion/Extrusion 2 2
Patient Device Interaction Problem 2 2
Loosening of Implant Not Related to Bone-Ingrowth 2 2
Physical Resistance 2 2
Use of Device Problem 2 2
Retraction Problem 2 2
Particulates 2 2
Positioning Problem 2 2
Scratched Material 2 2
Device Contamination with Chemical or Other Material 2 2
Device Contaminated During Manufacture or Shipping 2 2
Device Disinfection Or Sterilization Issue 2 2
Device Markings/Labelling Problem 2 2
Device Misassembled During Manufacturing /Shipping 2 2
Device Damaged Prior to Use 2 2
Difficult or Delayed Activation 2 2
Unstable 2 2
Misconnection 2 2
Delivered as Unsterile Product 2 2
Unintended Collision 2 2
Peeled/Delaminated 2 2
Contamination 2 2
Material Discolored 2 2
Disconnection 2 2
Difficult or Delayed Positioning 1 1
Partial Blockage 1 1
Thermal Decomposition of Device 1 1
Product Quality Problem 1 1
Material Rupture 1 1
Material Erosion 1 1
Insufficient Flow or Under Infusion 1 1
Fitting Problem 1 1
Unexpected Therapeutic Results 1 1
Misassembled 1 1
Failure to Disconnect 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 393 393
No Consequences Or Impact To Patient 276 276
Device Embedded In Tissue or Plaque 234 234
No Information 167 167
Foreign Body In Patient 143 143
Injury 83 83
No Clinical Signs, Symptoms or Conditions 70 70
No Patient Involvement 66 66
No Code Available 42 42
Insufficient Information 33 33
Pain 16 16
Unspecified Infection 16 16
Failure of Implant 12 12
Bone Fracture(s) 10 10
Tissue Damage 7 7
Cardiac Arrest 5 5
Not Applicable 5 5
Post Operative Wound Infection 4 4
Complaint, Ill-Defined 4 4
Spinal Column Injury 4 4
Swelling 4 4
Dysphagia/ Odynophagia 2 2
Metal Related Pathology 2 2
Purulent Discharge 2 2
Headache 2 2
Laceration(s) 2 2
Patient Problem/Medical Problem 2 2
Test Result 1 1
Burn, Thermal 1 1
Limited Mobility Of The Implanted Joint 1 1
Subluxation 1 1
Increased Appetite 1 1
Swelling/ Edema 1 1
Muscular Rigidity 1 1
Hemorrhage/Bleeding 1 1
Edema 1 1
Endophthalmitis 1 1
Bacterial Infection 1 1
Joint Swelling 1 1
Impaired Healing 1 1
Brain Injury 1 1
Discomfort 1 1
Seizures 1 1
Hematoma 1 1
Wound Dehiscence 1 1
Vessel Or Plaque, Device Embedded In 1 1
Abrasion 1 1
Perforation 1 1
Loss of Range of Motion 1 1
Ulcer 1 1
Pressure Sores 1 1
Hip Fracture 1 1
Hypoesthesia 1 1
Joint Dislocation 1 1
Numbness 1 1
Low Oxygen Saturation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Exactech, Inc. II Aug-11-2017
2 Medtronic Sofamor Danek USA Inc II Feb-09-2018
3 Smith & Nephew, Inc. II Jan-24-2018
4 Trilliant Surgical Ltd. II Jul-02-2018
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