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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
Regulation Description Surgical instrument motors and accessories/attachments.
Product CodeHWE
Regulation Number 878.4820
Device Class 1

MDR Year MDR Reports MDR Events
2016 4974 5561
2017 5074 6196
2018 3589 4495
2019 3452 4249
2020 3248 4035
2021 2415 2988

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Jam 3046 3046
Unintended System Motion 2779 2779
Output below Specifications 2293 2293
Fail-Safe Problem 2140 2286
Noise, Audible 2052 2052
Break 1651 1733
Device Operates Differently Than Expected 1526 1532
Physical Resistance/Sticking 1380 1534
Fracture 1177 1537
Overheating of Device 1173 1473
Device Inoperable 990 990
Partial Blockage 751 751
Mechanical Problem 599 601
Detachment of Device or Device Component 587 1125
Complete Loss of Power 581 581
Excessive Heating 471 471
Naturally Worn 419 419
Vibration 315 315
Sticking 301 426
Device Remains Activated 297 1066
Fluid Leak 293 660
Defective Device 276 276
Leak/Splash 253 429
Defective Component 247 247
Intermittent Loss of Power 235 235
Unexpected Shutdown 222 222
Detachment Of Device Component 216 221
Device-Device Incompatibility 193 193
Disassembly 188 868
Material Fragmentation 183 199
Intermittent Energy Output 177 177
Device Stops Intermittently 169 169
Failure to Cut 169 169
Air Leak 164 164
Self-Activation or Keying 152 152
Appropriate Term/Code Not Available 140 140
Material Deformation 137 144
Material Twisted/Bent 129 129
Temperature Problem 126 126
Metal Shedding Debris 112 257
Power Problem 111 111
Difficult To Position 106 106
Incorrect Or Inadequate Test Results 105 105
Protective Measures Problem 105 105
Failure of Device to Self-Test 101 101
Device Operational Issue 101 101
Loose or Intermittent Connection 98 98
Corroded 94 94
Battery Problem 92 93
Loss of Power 83 83
Unintended Power Up 83 136
Material Disintegration 76 182
Crack 74 74
Failure to Power Up 69 69
Bent 68 68
Material Separation 66 66
Dull, Blunt 66 66
Entrapment of Device 64 64
Unintended Movement 61 62
Component Missing 58 58
Flaked 53 185
Failure to Shut Off 52 52
Positioning Problem 50 148
Migration or Expulsion of Device 50 50
Difficult to Remove 50 50
Smoking 47 47
Device Slipped 42 42
Connection Problem 42 42
Fail-Safe Did Not Operate 42 42
Biocompatibility 41 515
Energy Output Problem 40 40
Failure to Charge 39 39
Torn Material 39 39
Adverse Event Without Identified Device or Use Problem 38 38
Electrical /Electronic Property Problem 36 36
Premature Separation 34 34
Occlusion Within Device 31 31
Charging Problem 31 31
Difficult to Insert 29 29
Difficult to Open or Close 29 149
Fitting Problem 27 27
Retraction Problem 24 24
Device Contamination with Chemical or Other Material 24 24
Material Integrity Problem 24 24
Insufficient Information 22 22
Degraded 21 21
Physical Resistance 20 20
Electrical Shorting 20 20
Obstruction of Flow 18 18
Device Emits Odor 18 18
Component Falling 17 17
Power Conditioning Problem 17 17
Compatibility Problem 17 17
Material Discolored 16 16
Moisture Damage 15 15
Melted 15 15
Delivered as Unsterile Product 14 87
Device Displays Incorrect Message 13 14
Device Reprocessing Problem 12 12
Mechanics Altered 12 12

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 7741 8961
No Patient Involvement 5708 8632
No Known Impact Or Consequence To Patient 5677 6533
No Clinical Signs, Symptoms or Conditions 3005 4099
No Information 237 303
Foreign Body In Patient 195 195
Device Embedded In Tissue or Plaque 170 170
No Code Available 161 161
Not Applicable 144 144
Burn(s) 79 79
Insufficient Information 76 118
Injury 39 39
Bone Fracture(s) 17 17
Tissue Damage 10 10
Unspecified Infection 8 8
Burn, Thermal 8 8
Laceration(s) 7 7
Pain 7 7
Patient Problem/Medical Problem 7 7
Superficial (First Degree) Burn 7 7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
Partial thickness (Second Degree) Burn 6 6
Abrasion 5 5
Failure of Implant 5 5
Radiation Exposure, Unintended 5 5
Unspecified Tissue Injury 5 5
Cardiac Perforation 4 4
Infiltration into Tissue 3 3
Therapeutic Effects, Unexpected 3 3
Swelling 2 2
Perforation 2 2
Skin Discoloration 2 3
Skin Irritation 2 2
Full thickness (Third Degree) Burn 2 2
Death 2 2
Arrhythmia 1 1
Hemorrhage/Bleeding 1 1
Hyperglycemia 1 1
Damage to Ligament(s) 1 1
Brain Injury 1 1
Complaint, Ill-Defined 1 1
Alteration In Body Temperature 1 1
Post Operative Wound Infection 1 1
Sprain 1 1
Wound Dehiscence 1 1
Hematoma 1 1
Visual Disturbances 1 1
Hip Fracture 1 1
Sedation 1 1
Osteolysis 1 1
Vascular Dissection 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Encore Medical, Lp II Jul-27-2019
2 Greatbatch Medical II Jun-01-2016
3 Stryker Instruments Div. of Stryker Corporation II Apr-27-2017
4 Stryker Instruments Div. of Stryker Corporation II Oct-18-2016
5 Synthes (USA) Products LLC II Dec-01-2016
6 Synthes (USA) Products LLC II Jul-12-2016
7 The Anspach Effort, Inc. II Jan-11-2018
8 The Anspach Effort, Inc. I Sep-27-2016
9 Zimmer Biomet, Inc. II Sep-22-2017
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