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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device instrument, surgical, orthopedic, ac-powered motor and accessory/attachment
Product CodeHWE
Regulation Number 878.4820
Device Class 1

MDR Year MDR Reports MDR Events
2018 3589 4495
2019 3452 4249
2020 3248 4035
2021 3140 3843
2022 3329 4021
2023 1159 1628

Device Problems MDRs with this Device Problem Events in those MDRs
Physical Resistance/Sticking 2593 2750
Mechanical Jam 2520 2520
Output below Specifications 2239 2239
Complete Loss of Power 1850 1850
Fracture 1438 2054
Noise, Audible 1292 1292
Break 1174 1233
Unintended System Motion 1104 1104
Excessive Heating 998 998
Detachment of Device or Device Component 874 1584
Overheating of Device 620 800
Fail-Safe Problem 443 595
Failure to Cut 415 415
Intermittent Loss of Power 391 391
Appropriate Term/Code Not Available 382 382
Fluid/Blood Leak 328 861
Device-Device Incompatibility 304 304
Device Remains Activated 247 953
Unexpected Shutdown 223 223
Vibration 210 210
Intermittent Energy Output 184 184
Device Operates Differently Than Expected 164 164
Leak/Splash 156 230
Material Fragmentation 142 218
Material Twisted/Bent 138 138
Material Disintegration 134 353
Device Inoperable 108 108
Naturally Worn 91 91
Mechanical Problem 87 89
Entrapment of Device 86 86
Premature Separation 78 78
Material Deformation 77 84
Device Stops Intermittently 72 72
Flaked 71 466
Crack 69 69
Fail-Safe Did Not Operate 69 70
Adverse Event Without Identified Device or Use Problem 65 65
Device Slipped 63 63
Material Separation 56 56
Unintended Power Up 48 61
Dull, Blunt 48 48
Detachment Of Device Component 47 47
Difficult to Open or Close 44 232
Unintended Movement 41 41
Disassembly 40 168
Energy Output Problem 37 37
Device Operational Issue 37 37
Material Integrity Problem 27 27
Difficult to Remove 27 27
Corroded 25 25
Compatibility Problem 23 23
Difficult To Position 22 22
Environmental Particulates 21 21
Contamination /Decontamination Problem 20 20
Positioning Problem 18 40
Smoking 18 18
Electrical /Electronic Property Problem 18 18
Loose or Intermittent Connection 17 17
Device Emits Odor 15 15
Metal Shedding Debris 15 73
Difficult or Delayed Separation 14 14
Sticking 13 55
Degraded 13 13
Connection Problem 13 13
Defective Component 13 13
Defective Device 13 13
Component Missing 12 12
Device Reprocessing Problem 12 12
Protective Measures Problem 10 10
No Apparent Adverse Event 9 9
Biocompatibility 9 107
Device Markings/Labelling Problem 9 9
Unintended Ejection 9 10
Fire 9 9
Improper or Incorrect Procedure or Method 9 9
Fitting Problem 9 9
Delivered as Unsterile Product 9 67
Difficult to Insert 9 9
Separation Problem 9 9
Positioning Failure 8 8
Circuit Failure 8 8
Use of Device Problem 8 8
Insufficient Information 8 8
Temperature Problem 8 8
Output Problem 8 8
Packaging Problem 7 7
Device Damaged by Another Device 7 7
Tear, Rip or Hole in Device Packaging 6 6
Scratched Material 5 5
Failure to Auto Stop 5 5
Contamination 5 5
Failure to Power Up 5 5
Loosening of Implant Not Related to Bone-Ingrowth 5 5
Material Split, Cut or Torn 4 4
Material Rupture 4 4
Self-Activation or Keying 4 4
Air Leak 4 4
Bent 4 4
Mechanics Altered 4 4
Therapeutic or Diagnostic Output Failure 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 7915 10300
No Consequences Or Impact To Patient 6844 7891
No Known Impact Or Consequence To Patient 1869 2490
No Patient Involvement 759 2359
Foreign Body In Patient 337 337
Insufficient Information 152 228
Not Applicable 134 134
No Code Available 109 109
Device Embedded In Tissue or Plaque 83 83
No Information 60 126
Burn(s) 51 51
Injury 36 36
Skin Tears 26 26
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 18 18
Bone Fracture(s) 14 14
Unspecified Tissue Injury 9 9
Superficial (First Degree) Burn 9 9
Tissue Damage 8 8
Burn, Thermal 8 8
Pain 8 8
Unspecified Infection 7 7
Laceration(s) 7 7
Failure of Implant 6 6
Cardiac Perforation 4 4
Infiltration into Tissue 3 3
Brain Injury 3 3
Abrasion 3 3
Patient Problem/Medical Problem 3 3
Skin Irritation 2 2
Full thickness (Third Degree) Burn 2 2
Limb Fracture 1 1
Alteration In Body Temperature 1 1
Skin Discoloration 1 2
Hearing Impairment 1 1
Shock 1 1
Arrhythmia 1 1
Sprain 1 1
Visual Disturbances 1 1
Rupture 1 1
Partial thickness (Second Degree) Burn 1 1
Wound Dehiscence 1 1
Perforation 1 1
Nerve Damage 1 1
Swelling/ Edema 1 1
Hemorrhage/Bleeding 1 1
Damage to Ligament(s) 1 1
Tinnitus 1 1
Osteolysis 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Encore Medical, Lp II Jul-27-2019
2 The Anspach Effort, Inc. II Jan-11-2018
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