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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


Premarket Reviews
ManufacturerDecision
MCGINLEY INNOVATIONS
  SUBSTANTIALLY EQUIVALENT 1
ORTHO SOLUTIONS LIMITED
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 3793 3793
2015 5566 5566
2016 4974 5561
2017 5074 6196
2018 3589 4495
2019 3452 4249
2020 3248 4035
2021 3140 3843
2022 3327 4019
2023 3399 4241
2024 777 1054

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Jam 5416 5416
Device Inoperable 3342 3342
Physical Resistance/Sticking 3300 3460
Unintended System Motion 3049 3049
Break 2962 3044
Device Operates Differently Than Expected 2826 2832
Noise, Audible 2756 2756
Complete Loss of Power 2488 2488
Output below Specifications 2460 2460
Fail-Safe Problem 2178 2330
Fracture 1820 2505
Overheating of Device 1681 2038
Excessive Heating 1280 1280
Detachment of Device or Device Component 1077 1890
Partial Blockage 1016 1016
Mechanical Problem 887 889
Disassembly 810 1490
Appropriate Term/Code Not Available 762 762
Sticking 691 816
Naturally Worn 621 621
Failure to Cut 514 514
Intermittent Loss of Power 496 496
Leak/Splash 487 663
Defective Device 479 479
Device Remains Activated 477 1421
Battery Problem 465 466
Unintended Power Up 442 498
Fluid/Blood Leak 436 1026
Vibration 426 426
Device-Device Incompatibility 401 401
Defective Component 377 377
Device Stops Intermittently 319 319
Loose or Intermittent Connection 306 306
Material Fragmentation 302 391
Detachment Of Device Component 298 303
Loss of Power 283 283
Temperature Problem 273 273
Failure to Power Up 250 250
Device Slipped 247 247
Self-Activation or Keying 241 241
Unexpected Shutdown 235 235
Metal Shedding Debris 230 375
Component Missing 214 214
Air Leak 210 210
Power Problem 206 206
Intermittent Energy Output 188 188
Corroded 183 183
Material Deformation 170 177
Material Disintegration 168 405
Failure to Charge 153 153
Material Twisted/Bent 148 148
Device Disinfection Or Sterilization Issue 138 138
Crack 125 125
Material Separation 120 120
Failure to Shut Off 120 120
Flaked 114 815
Entrapment of Device 113 113
Difficult To Position 112 112
Protective Measures Problem 108 108
Premature Separation 107 107
Incorrect Or Inadequate Test Results 106 106
Unintended Movement 104 104
Failure of Device to Self-Test 102 102
Device Operational Issue 102 102
Connection Problem 101 101
Positioning Problem 99 197
Adverse Event Without Identified Device or Use Problem 98 98
Power Conditioning Problem 93 93
Bent 92 92
Fail-Safe Did Not Operate 92 121
Smoking 86 86
Dull, Blunt 83 83
Physical Resistance 82 82
Material Integrity Problem 80 80
Difficult to Remove 79 79
Difficult to Open or Close 72 262
Charging Problem 71 71
Electrical /Electronic Property Problem 63 63
Fitting Problem 57 57
Degraded 56 56
Component Falling 56 56
Migration or Expulsion of Device 55 55
Device Displays Incorrect Message 55 56
Torn Material 55 55
Energy Output Problem 45 45
Difficult to Insert 44 44
Biocompatibility 42 516
Device Contamination with Chemical or Other Material 39 39
Device Emits Odor 39 39
Premature Discharge of Battery 38 38
Occlusion Within Device 36 36
Retraction Problem 36 36
Device Reprocessing Problem 34 34
Melted 34 34
Compatibility Problem 34 34
Insufficient Information 33 33
Application Interface Becomes Non-Functional Or Program Exits Abnormally 30 30
Contamination /Decontamination Problem 27 27
Difficult or Delayed Activation 24 24
Improper or Incorrect Procedure or Method 24 24

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 10733 13768
No Known Impact Or Consequence To Patient 10686 11542
No Consequences Or Impact To Patient 8206 9426
No Patient Involvement 7990 10914
No Information 1640 1706
Foreign Body In Patient 416 416
Device Embedded In Tissue or Plaque 308 308
Insufficient Information 293 401
No Code Available 207 207
Not Applicable 144 144
Burn(s) 126 126
Injury 43 43
Bone Fracture(s) 31 31
Skin Tears 26 26
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 18 18
Burn, Thermal 16 16
Unspecified Tissue Injury 15 15
Sedation 14 14
Partial thickness (Second Degree) Burn 13 13
Laceration(s) 13 13
Pain 12 12
Tissue Damage 12 12
Failure of Implant 11 11
Therapeutic Effects, Unexpected 10 10
Superficial (First Degree) Burn 10 10
Unspecified Infection 9 9
Abrasion 8 8
Hemorrhage/Bleeding 7 7
Patient Problem/Medical Problem 7 7
Radiation Exposure, Unintended 5 5
Cardiac Perforation 4 4
Infiltration into Tissue 3 3
Perforation 3 3
Skin Irritation 3 3
Brain Injury 3 3
Wound Dehiscence 2 2
Skin Discoloration 2 3
Paralysis 2 2
Damage to Ligament(s) 2 2
Death 2 2
Swelling 2 2
Post Operative Wound Infection 2 2
Non-union Bone Fracture 2 2
Full thickness (Third Degree) Burn 2 2
Vascular Dissection 1 1
Caustic/Chemical Burns 1 1
Alteration In Body Temperature 1 1
Osteolysis 1 1
Impaired Healing 1 1
Spinal Cord Injury 1 1
Suture Abrasion 1 1
Limb Fracture 1 1
Swelling/ Edema 1 1
Fall 1 1
Arrhythmia 1 1
Exposure to Body Fluids 1 1
Hyperglycemia 1 1
Hearing Impairment 1 1
Hematoma 1 1
Nerve Damage 1 1
Shock 1 1
Sprain 1 1
Tinnitus 1 1
Visual Disturbances 1 1
Burning Sensation 1 1
Therapeutic Response, Increased 1 1
Discomfort 1 1
Complaint, Ill-Defined 1 1
Hip Fracture 1 1
Rupture 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. II Sep-08-2009
2 EXP Pharmaceutical Services Corp II Jul-24-2015
3 Encore Medical, Lp II Jul-27-2019
4 Greatbatch Medical II Jun-01-2016
5 Linvatec Corp. dba ConMed Linvatec II Apr-04-2011
6 Linvatec Corp. dba ConMed Linvatec I Oct-01-2009
7 Medtronic Sofamor Danek USA Inc II Jan-12-2015
8 Smith & Nephew, Inc., Endoscopy Div. II Oct-22-2015
9 Stryker Instruments Div. of Stryker Corporation II Apr-27-2017
10 Stryker Instruments Div. of Stryker Corporation II Oct-18-2016
11 Stryker Instruments Div. of Stryker Corporation III May-07-2015
12 Stryker Instruments Div. of Stryker Corporation II Feb-09-2015
13 Stryker Instruments Div. of Stryker Corporation II Nov-05-2014
14 Stryker Instruments Div. of Stryker Corporation II Sep-13-2010
15 Stryker Instruments Div. of Stryker Corporation II Mar-30-2009
16 Synthes (USA) Products LLC II Dec-01-2016
17 Synthes (USA) Products LLC II Jul-12-2016
18 Synthes USA (HQ), Inc. II Dec-02-2011
19 Synthes USA (HQ), Inc. II Oct-26-2009
20 Synthes USA HQ, Inc. II Dec-31-2013
21 Synthes, Inc. II Mar-23-2015
22 The Anspach Effort, Inc. II Jan-11-2018
23 The Anspach Effort, Inc. I Sep-27-2016
24 The Anspach Effort, Inc. II Apr-30-2015
25 W & H DentalWerk Buermoos GMBH II Jul-25-2011
26 Zimmer Biomet, Inc. II Sep-22-2017
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