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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 2009 2009
2022 835 835

Device Problems MDRs with this Device Problem Events in those MDRs
Break 6366 6366
Crack 805 805
Fracture 519 519
Device-Device Incompatibility 364 364
Naturally Worn 363 363
Material Twisted/Bent 334 334
Scratched Material 146 146
Material Deformation 136 136
Appropriate Term/Code Not Available 130 130
Contamination /Decontamination Problem 114 114
Adverse Event Without Identified Device or Use Problem 63 63
Component Missing 47 47
Detachment of Device or Device Component 45 45
Loose or Intermittent Connection 43 43
Material Integrity Problem 42 42
Mechanical Jam 42 42
Connection Problem 38 38
Unintended Movement 33 33
Insufficient Information 32 32
Entrapment of Device 24 24
Physical Resistance/Sticking 23 23
Device Contamination with Chemical or Other Material 22 22
Difficult to Remove 19 19
Mechanical Problem 18 18
Dull, Blunt 16 16
Failure to Disconnect 15 15
Material Discolored 15 15
Disassembly 14 14
Material Fragmentation 12 12
Device Slipped 12 12
Use of Device Problem 10 10
Detachment Of Device Component 10 10
No Apparent Adverse Event 9 9
Illegible Information 9 9
Bent 7 7
Device Operates Differently Than Expected 7 7
Device Damaged by Another Device 7 7
Defective Device 6 6
Structural Problem 6 6
Corroded 6 6
Device Reprocessing Problem 6 6
Fitting Problem 6 6
Device Damaged Prior to Use 5 5
Defective Component 4 4
Degraded 4 4
Off-Label Use 4 4
Device Issue 4 4
Compatibility Problem 4 4
Separation Problem 4 4
Positioning Problem 4 4
Material Split, Cut or Torn 3 3
Flaked 3 3
Delivered as Unsterile Product 3 3
Device Difficult to Setup or Prepare 3 3
Difficult to Insert 2 2
Problem with Sterilization 2 2
Sticking 2 2
Material Rupture 2 2
Material Disintegration 2 2
Device Dislodged or Dislocated 2 2
Device Difficult to Maintain 2 2
Failure to Cut 2 2
Deformation Due to Compressive Stress 2 2
Failure to Clean Adequately 2 2
Difficult or Delayed Separation 1 1
Missing Information 1 1
Device Fell 1 1
Missing Test Results 1 1
Explosion 1 1
Delamination 1 1
Device Or Device Fragments Location Unknown 1 1
Blocked Connection 1 1
Separation Failure 1 1
Solder Joint Fracture 1 1
Split 1 1
Loss of Osseointegration 1 1
Osseointegration Problem 1 1
Material Protrusion/Extrusion 1 1
Device Disinfection Or Sterilization Issue 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

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 2880 2880
No Information 854 854
No Known Impact Or Consequence To Patient 526 526
No Code Available 206 206
Insufficient Information 146 146
Not Applicable 109 109
No Patient Involvement 105 105
Foreign Body In Patient 38 38
Device Embedded In Tissue or Plaque 13 13
Pain 6 6
Injury 4 4
Unspecified Infection 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
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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