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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 1687 1687

Device Problems MDRs with this Device Problem Events in those MDRs
Break 7012 7012
Crack 875 875
Fracture 566 566
Naturally Worn 463 463
Device-Device Incompatibility 405 405
Material Twisted/Bent 337 337
Scratched Material 150 150
Material Deformation 146 146
Appropriate Term/Code Not Available 130 130
Contamination /Decontamination Problem 127 127
Adverse Event Without Identified Device or Use Problem 68 68
Material Integrity Problem 50 50
Detachment of Device or Device Component 49 49
Mechanical Jam 48 48
Component Missing 48 48
Loose or Intermittent Connection 43 43
Connection Problem 38 38
Unintended Movement 35 35
Insufficient Information 32 32
Entrapment of Device 26 26
Physical Resistance/Sticking 24 24
Device Contamination with Chemical or Other Material 22 22
Difficult to Remove 20 20
Mechanical Problem 19 19
No Apparent Adverse Event 19 19
Failure to Disconnect 17 17
Dull, Blunt 16 16
Material Discolored 16 16
Disassembly 14 14
Material Fragmentation 14 14
Illegible Information 14 14
Device Slipped 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
Difficult to Insert 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
Improper or Incorrect Procedure or Method 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
Device Handling Problem 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/Blood Leak 1 1
Failure to Discharge 1 1
Disconnection 1 1
Accessory Incompatible 1 1
Burst Container or Vessel 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 Separation Problem 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 3700 3700
No Information 854 854
No Known Impact Or Consequence To Patient 526 526
No Code Available 206 206
Insufficient Information 179 179
Not Applicable 109 109
No Patient Involvement 105 105
Foreign Body In Patient 40 40
Device Embedded In Tissue or Plaque 13 13
Pain 6 6
Unspecified Infection 5 5
Failure of Implant 4 4
Injury 4 4
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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