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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
2019 24 24
2020 16 16
2021 11 11
2022 10 10
2023 12 12
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Break 32 32
Material Deformation 14 14
Fracture 7 7
Detachment of Device or Device Component 5 5
Material Twisted/Bent 4 4
Mechanical Jam 4 4
Mechanical Problem 3 3
Device Slipped 2 2
Device-Device Incompatibility 2 2
Corroded 2 2
Degraded 2 2
Mechanics Altered 2 2
Physical Resistance/Sticking 2 2
Material Integrity Problem 1 1
No Apparent Adverse Event 1 1
Loose or Intermittent Connection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 31 31
No Known Impact Or Consequence To Patient 18 18
No Consequences Or Impact To Patient 17 17
No Code Available 3 3
No Patient Involvement 2 2
No Information 2 2
Foreign Body In Patient 1 1
Insufficient Information 1 1
Nerve Damage 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Aesculap Implant Systems LLC II Jul-19-2022
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