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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device spinal channeling instrument, vertebroplasty
Definition Create channels in the existing spinal bone structure for the flow of polymethylmethacrylate bone cement (PMMA) prior to a vertebroplasty procedure. Treatment of pathological compression fractures of the vertebral body that may result from osteoporosis, benign lesions, and/or malignant lesions.
Product CodeOCJ
Regulation Number 888.4540
Device Class 1

MDR Year MDR Reports MDR Events
2014 1 1
2015 1 1
2018 1 1
2021 1 1
2022 1 1
2023 2 2
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Fracture 5 5
Break 2 2
Unraveled Material 1 1
Activation, Positioning or Separation Problem 1 1
Material Deformation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Foreign Body In Patient 4 4
Device Embedded In Tissue or Plaque 2 2
No Clinical Signs, Symptoms or Conditions 1 1
No Known Impact Or Consequence To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 DePuy Spine, Inc. II Apr-27-2011
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