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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 553 766

Device Problems MDRs with this Device Problem Events in those MDRs
Physical Resistance/Sticking 2453 2609
Mechanical Jam 2399 2399
Output below Specifications 2231 2231
Complete Loss of Power 1722 1722
Fracture 1398 1993
Noise, Audible 1271 1271
Break 1127 1186
Unintended System Motion 1090 1090
Excessive Heating 955 955
Detachment of Device or Device Component 827 1484
Overheating of Device 604 767
Fail-Safe Problem 443 595
Failure to Cut 391 391
Intermittent Loss of Power 369 369
Fluid/Blood Leak 320 842
Appropriate Term/Code Not Available 311 311
Device-Device Incompatibility 292 292
Device Remains Activated 235 930
Unexpected Shutdown 223 223
Vibration 207 207
Intermittent Energy Output 183 183
Device Operates Differently Than Expected 164 164
Leak/Splash 147 221
Material Twisted/Bent 135 135
Material Fragmentation 134 200
Material Disintegration 125 302
Device Inoperable 108 108
Naturally Worn 89 89
Mechanical Problem 85 87
Entrapment of Device 84 84
Material Deformation 77 84
Device Stops Intermittently 72 72
Premature Separation 68 68
Crack 67 67
Flaked 66 404
Adverse Event Without Identified Device or Use Problem 65 65
Fail-Safe Did Not Operate 61 61
Material Separation 56 56
Device Slipped 53 53
Dull, Blunt 48 48
Detachment Of Device Component 47 47
Unintended Power Up 44 57
Difficult to Open or Close 42 198
Unintended Movement 41 41
Disassembly 40 168
Energy Output Problem 37 37
Device Operational Issue 37 37
Difficult to Remove 27 27
Corroded 23 23
Compatibility Problem 23 23
Difficult To Position 22 22
Environmental Particulates 19 19
Contamination /Decontamination Problem 19 19
Material Integrity Problem 18 18
Positioning Problem 18 40
Smoking 18 18
Electrical /Electronic Property Problem 18 18
Loose or Intermittent Connection 17 17
Metal Shedding Debris 15 73
Sticking 13 55
Device Emits Odor 13 13
Connection Problem 13 13
Defective Component 13 13
Difficult or Delayed Separation 13 13
Degraded 12 12
Device Reprocessing Problem 12 12
Component Missing 11 11
Defective Device 11 11
Protective Measures Problem 10 10
Biocompatibility 9 107
Fitting Problem 9 9
Device Markings/Labelling Problem 9 9
Unintended Ejection 9 10
Fire 9 9
Difficult to Insert 9 9
Delivered as Unsterile Product 9 67
Separation Problem 9 9
Improper or Incorrect Procedure or Method 8 8
Use of Device Problem 8 8
Positioning Failure 8 8
Temperature Problem 8 8
No Apparent Adverse Event 8 8
Insufficient Information 8 8
Output Problem 8 8
Device Damaged by Another Device 7 7
Circuit Failure 7 7
Packaging Problem 6 6
Loosening of Implant Not Related to Bone-Ingrowth 5 5
Scratched Material 5 5
Contamination 5 5
Failure to Power Up 5 5
Material Rupture 4 4
Self-Activation or Keying 4 4
Air Leak 4 4
Bent 4 4
Therapeutic or Diagnostic Output Failure 4 4
Material Split, Cut or Torn 4 4
Mechanics Altered 4 4
Failure to Auto Stop 4 4
Communication or Transmission Problem 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 7348 9477
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 315 315
Insufficient Information 140 213
Not Applicable 134 134
No Code Available 109 109
Device Embedded In Tissue or Plaque 78 78
No Information 60 126
Burn(s) 51 51
Injury 36 36
Skin Tears 26 26
Bone Fracture(s) 14 14
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 12 12
Superficial (First Degree) Burn 9 9
Unspecified Tissue Injury 9 9
Pain 8 8
Burn, Thermal 8 8
Tissue Damage 8 8
Unspecified Infection 7 7
Laceration(s) 7 7
Failure of Implant 6 6
Cardiac Perforation 4 4
Brain Injury 3 3
Patient Problem/Medical Problem 3 3
Abrasion 3 3
Infiltration into Tissue 3 3
Skin Irritation 2 2
Full thickness (Third Degree) Burn 2 2
Swelling/ Edema 1 1
Limb Fracture 1 1
Sprain 1 1
Tinnitus 1 1
Perforation 1 1
Skin Discoloration 1 2
Damage to Ligament(s) 1 1
Nerve Damage 1 1
Arrhythmia 1 1
Wound Dehiscence 1 1
Hearing Impairment 1 1
Hemorrhage/Bleeding 1 1
Partial thickness (Second Degree) Burn 1 1
Alteration In Body Temperature 1 1
Osteolysis 1 1
Visual Disturbances 1 1
Rupture 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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