H6: problem code:2017 component code: 568 type of investigation: 3331; 10 investigation findings: 4248 investigations conclusions: 18 h10: visual inspection of both osseoscrew's confirms the event.The expansion region was not collapsed on either screw.The reported event states the surgeon used a regular osseoscrew driver to remove the screws.The surgical technique guide indicates osseoscrew retrieval tool (pn 54900-30) is to be used to engage and remove the distal tip of the screw remaining in the vertebral body.The tool is used to advance the distal tip of the osseoscrew anteriorly; this will collapse the expansion region.The surgeon is to confirm the distal tip is collapsed using lateral fluoro images.Once the expansion region is collapsed, rotate counterclockwise and proceed to back the distal tip out.Based on information provided, the surgical technique guide was not followed.Labeling review: the indications for use as stated in ins-101; the osseoscrew system (for use with the zodiac spinal fixation system and illico mis posterior fixation system) is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion.Warnings 5.Once the osseoscrew implant has been deployed, it may be difficult to un-deploy, re-position, or remove; therefore, it is important to confirm proper placement of the osseoscrew prior to deploying the expansion feature by use of fluoroscopy or other suitable imaging technique.
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