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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device bender
Product CodeHXW
Regulation Number 888.4540
Device Class 1

MDR Year MDR Reports MDR Events
2014 4 4
2015 11 11
2016 30 30
2017 22 22
2018 43 43
2019 24 24
2020 16 16
2021 11 11
2022 10 10
2023 12 12
2024 19 19

Device Problems MDRs with this Device Problem Events in those MDRs
Break 60 60
Fracture 45 45
Material Deformation 27 27
Device Inoperable 16 16
Disassembly 15 15
Material Twisted/Bent 10 10
Detachment of Device or Device Component 8 8
Device-Device Incompatibility 8 8
Device Operates Differently Than Expected 6 6
Mechanical Jam 5 5
Sticking 4 4
Device Operational Issue 3 3
Physical Resistance/Sticking 3 3
Mechanical Problem 3 3
Naturally Worn 2 2
Device Slipped 2 2
Mechanics Altered 2 2
Loose or Intermittent Connection 2 2
Corroded 2 2
Degraded 2 2
Component Missing 1 1
Device Maintenance Issue 1 1
No Apparent Adverse Event 1 1
Device Or Device Fragments Location Unknown 1 1
Material Integrity Problem 1 1
Defective Device 1 1
Difficult to Open or Close 1 1
Migration or Expulsion of Device 1 1
Unintended Movement 1 1
Separation Failure 1 1
Difficult to Advance 1 1
Difficult to Remove 1 1
Failure To Adhere Or Bond 1 1
Material Fragmentation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 93 93
No Clinical Signs, Symptoms or Conditions 48 48
No Consequences Or Impact To Patient 34 34
No Code Available 7 7
No Information 7 7
No Patient Involvement 7 7
Sedation 2 2
Injury 1 1
Foreign Body In Patient 1 1
Nerve Damage 1 1
Insufficient Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Aesculap Implant Systems LLC II Jul-19-2022
2 Synthes, Inc. II Jan-28-2015
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