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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 30 30
2026 17 17

Device Problems MDRs with this Device Problem Events in those MDRs
Break 63 63
Material Deformation 40 40
Device-Device Incompatibility 12 12
Material Twisted/Bent 11 11
Material Integrity Problem 3 3
Detachment of Device or Device Component 3 3
Corroded 3 3
Device Slipped 2 2
Physical Resistance/Sticking 2 2
Degraded 2 2
Mechanics Altered 2 2
Fracture 2 2
Entrapment of Device 1 1
No Apparent Adverse Event 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 101 101
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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