Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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 2540 3470

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Jam 5651 5651
Physical Resistance/Sticking 3681 3841
Device Inoperable 3342 3342
Break 3117 3199
Unintended System Motion 3083 3084
Noise, Audible 2827 2827
Device Operates Differently Than Expected 2826 2832
Complete Loss of Power 2772 2772
Output below Specifications 2479 2479
Fail-Safe Problem 2179 2331
Fracture 1892 2603
Overheating of Device 1777 2139
Excessive Heating 1421 1421
Detachment of Device or Device Component 1175 2095
Partial Blockage 1016 1016
Mechanical Problem 925 927
Appropriate Term/Code Not Available 915 915
Disassembly 810 1490
Sticking 691 816
Naturally Worn 657 657
Failure to Cut 592 592
Intermittent Loss of Power 554 554
Leak/Splash 499 675
Device Remains Activated 498 1473
Defective Device 495 495
Fluid/Blood Leak 466 1086
Battery Problem 465 466
Device-Device Incompatibility 460 460
Unintended Power Up 443 499
Vibration 427 427
Defective Component 377 377
Material Fragmentation 329 422
Device Stops Intermittently 319 319
Loose or Intermittent Connection 308 308
Detachment Of Device Component 298 303
Loss of Power 289 289
Temperature Problem 273 273
Device Slipped 273 273
Failure to Power Up 255 255
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 210 210
Corroded 208 208
Intermittent Energy Output 191 191
Material Disintegration 188 474
Material Deformation 182 189
Material Twisted/Bent 169 169

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 12362 16049
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
Insufficient Information 445 584
Foreign Body In Patient 434 434
Device Embedded In Tissue or Plaque 308 308
No Code Available 207 207
Not Applicable 144 144
Burn(s) 128 128
Injury 43 43
Bone Fracture(s) 31 31
Skin Tears 26 26
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 19 19
Unspecified Tissue Injury 16 16
Burn, Thermal 16 16
Sedation 14 14
Partial thickness (Second Degree) Burn 13 13
Pain 13 13
Laceration(s) 13 13
Tissue Damage 12 12
Superficial (First Degree) Burn 11 11
Failure of Implant 11 11
Therapeutic Effects, Unexpected 10 10
Unspecified Infection 9 9
Abrasion 8 8
Patient Problem/Medical Problem 7 7
Hemorrhage/Bleeding 7 7
Radiation Exposure, Unintended 5 5
Cardiac Perforation 4 4
Infiltration into Tissue 3 3
Perforation 3 3
Brain Injury 3 3
Skin Irritation 3 3
Post Operative Wound Infection 2 2
Skin Discoloration 2 3
Paralysis 2 2
Swelling 2 2
Non-union Bone Fracture 2 2
Death 2 2
Wound Dehiscence 2 2
Full thickness (Third Degree) Burn 2 2
Damage to Ligament(s) 2 2
Alteration In Body Temperature 1 1
Suture Abrasion 1 1
Rupture 1 1
Hematoma 1 1
Visual Disturbances 1 1
Burning Sensation 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
-
-