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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device bender
Regulation Description Orthopedic manual surgical instrument.
Product CodeHXW
Regulation Number 888.4540
Device Class 1

MDR Year MDR Reports MDR Events
2020 16 16
2021 11 11
2022 10 10
2023 12 12
2024 25 25
2025 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Break 37 37
Material Deformation 28 28
Device-Device Incompatibility 8 8
Material Twisted/Bent 8 8
Material Integrity Problem 3 3
Device Slipped 2 2
Physical Resistance/Sticking 2 2
Degraded 2 2
Mechanics Altered 2 2
Detachment of Device or Device Component 2 2
Corroded 2 2
Entrapment of Device 1 1
No Apparent Adverse Event 1 1
Fracture 1 1
Loose or Intermittent Connection 1 1
Mechanical Jam 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 57 57
No Consequences Or Impact To Patient 9 9
No Known Impact Or Consequence To Patient 7 7
Foreign Body In Patient 2 2
No Information 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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