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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device cement, bone, pre-formed, modular, polymeric, vertebroplasty
Regulation Description Polymethylmethacrylate (PMMA) bone cement.
Definition Reduction of vertebral body fractures in conjunction with PMMA bone cement cleared for vertebroplasty and restoration of vertebral body height.
Product CodeOBL
Regulation Number 888.3027
Device Class 2

MDR Year MDR Reports MDR Events
2021 1 1
2022 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Break 1 1
Positioning Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1 1
Insufficient Information 1 1

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