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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device impactor
Product CodeHWA
Regulation Number 888.4540
Device Class 1

MDR Year MDR Reports MDR Events
2017 1404 1404
2018 1609 1609
2019 1550 1550
2020 1477 1477
2021 2010 2010
2022 1373 1373

Device Problems MDRs with this Device Problem Events in those MDRs
Break 6799 6799
Crack 853 853
Fracture 546 546
Naturally Worn 413 413
Device-Device Incompatibility 383 383
Material Twisted/Bent 337 337
Scratched Material 148 148
Material Deformation 140 140
Appropriate Term/Code Not Available 130 130
Contamination /Decontamination Problem 116 116
Adverse Event Without Identified Device or Use Problem 68 68
Detachment of Device or Device Component 48 48
Mechanical Jam 47 47
Component Missing 47 47
Material Integrity Problem 46 46
Loose or Intermittent Connection 43 43
Connection Problem 38 38
Unintended Movement 35 35
Insufficient Information 32 32
Entrapment of Device 25 25
Physical Resistance/Sticking 23 23
Device Contamination with Chemical or Other Material 22 22
Mechanical Problem 19 19
Difficult to Remove 19 19
Failure to Disconnect 17 17
Dull, Blunt 16 16
Material Discolored 16 16
Disassembly 14 14
Material Fragmentation 13 13
Device Slipped 12 12
No Apparent Adverse Event 12 12
Illegible Information 12 12
Use of Device Problem 10 10
Detachment Of Device Component 10 10
Bent 7 7
Device Operates Differently Than Expected 7 7
Device Damaged by Another Device 7 7
Structural Problem 6 6
Defective Device 6 6
Corroded 6 6
Device Reprocessing Problem 6 6
Fitting Problem 6 6
Device Damaged Prior to Use 5 5
Off-Label Use 5 5
Compatibility Problem 5 5
Device Issue 4 4
Defective Component 4 4
Flaked 4 4
Degraded 4 4
Positioning Problem 4 4
Separation Problem 4 4
Material Split, Cut or Torn 3 3
Delivered as Unsterile Product 3 3
Device Difficult to Setup or Prepare 3 3
Deformation Due to Compressive Stress 3 3
Failure to Cut 2 2
Device Dislodged or Dislocated 2 2
Difficult to Insert 2 2
Problem with Sterilization 2 2
Sticking 2 2
Material Rupture 2 2
Material Disintegration 2 2
Device Difficult to Maintain 2 2
Failure to Clean Adequately 2 2
Missing Information 1 1
Therapeutic or Diagnostic Output Failure 1 1
Missing Test Results 1 1
Patient Device Interaction Problem 1 1
Explosion 1 1
Difficult or Delayed Separation 1 1
Device Fell 1 1
Fluid Leak 1 1
Failure to Discharge 1 1
Disconnection 1 1
Accessory Incompatible 1 1
Burst Container or Vessel 1 1
Improper or Incorrect Procedure or Method 1 1
Peeled/Delaminated 1 1
Pitted 1 1
Imprecision 1 1
Misconnection 1 1
Device Disinfection Or Sterilization Issue 1 1
Material Protrusion/Extrusion 1 1
Osseointegration Problem 1 1
Solder Joint Fracture 1 1
Split 1 1
Loss of Osseointegration 1 1
Device Or Device Fragments Location Unknown 1 1
Blocked Connection 1 1
Separation Failure 1 1
Delamination 1 1
Activation, Positioning or SeparationProblem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 4231 4231
No Clinical Signs, Symptoms or Conditions 3398 3398
No Information 854 854
No Known Impact Or Consequence To Patient 526 526
No Code Available 206 206
Insufficient Information 167 167
Not Applicable 109 109
No Patient Involvement 105 105
Foreign Body In Patient 39 39
Device Embedded In Tissue or Plaque 13 13
Pain 6 6
Unspecified Infection 5 5
Injury 4 4
Failure of Implant 3 3
Bone Fracture(s) 3 3
Reaction 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Hematoma 1 1
Sedation 1 1
Non-union Bone Fracture 1 1
Joint Disorder 1 1
Thrombosis 1 1
Inadequate Osseointegration 1 1
Osteopenia/ Osteoporosis 1 1
Patient Problem/Medical Problem 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Encore Medical, Lp II Mar-08-2017
2 Enztec Limited II Jan-24-2020
3 Exactech, Inc. II Sep-10-2019
4 XTANT Medical II Jul-04-2020
5 Zimmer Biomet, Inc. II Feb-14-2018
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