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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 23 23

Device Problems MDRs with this Device Problem Events in those MDRs
Break 40 40
Material Deformation 28 28
Material Twisted/Bent 10 10
Device-Device Incompatibility 8 8
Fracture 7 7
Detachment of Device or Device Component 5 5
Mechanical Jam 4 4
Mechanical Problem 3 3
Material Integrity Problem 3 3
Device Slipped 2 2
Physical Resistance/Sticking 2 2
Degraded 2 2
Mechanics Altered 2 2
Corroded 2 2
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 52 52
No Known Impact Or Consequence To Patient 18 18
No Consequences Or Impact To Patient 17 17
No Code Available 3 3
No Information 2 2
No Patient Involvement 2 2
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
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