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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device intervertebral fusion device with bone graft, solid-sphere, lumbar
Definition Intended to be inserted between the vertebral bodies into the disc space from l3 to s1 to provide stabilization and to help promote intervertebral body fusion. To be used with bone graft, for holding bone parts in alignment while they heal. Not intended for use in motion-sparing, non-fusion procedures, helps promote intervertebral body fusion, please reference: https://www.federalregister.gov/documents/2023/03/30/2023-06566/medical-devices-orthopedic-devices-classification-of-spinal-spheres-for-use-in-intervertebral-fusion.
Product CodeNVR
Device Class 3

MDR Year MDR Reports MDR Events
2015 1 1
2016 1 1
2017 1 1
2021 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 3 3
Migration or Expulsion of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 2 2
Unspecified Infection 1 1
Neuropathy 1 1
Pain 1 1
Pneumothorax 1 1
Swelling 1 1
Numbness 1 1
Low Oxygen Saturation 1 1

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