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Device Problem
Migration or Expulsion of Device (1395)
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Patient Problems
Unspecified Infection (1930); Impaired Healing (2378)
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Event Date 06/11/2013 |
Event Type
Injury
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Event Description
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This report is being filed after the subsequent review of the following journal article, "scalp necrosis following peroperative embolization for meningeal tumors: two cautionary tales" (2013).Kirkman, m.A., sethi, h., & kitchen, n.D.Acta neurochir, 15, 1413-1415.A report was done on preoperative embolization for meningeal tumors.In the report a (b)(6) female developed necrosis after a craniotomy that healed poorly and had serous discharge for several months.In two areas of the necrosis there was a synthes matrixneuro plate and screw protruding posteriorly and a synthes matrixneuro screw protruding anteriorly.The synthes matrixneuro plate and screws were subsequently explanted.This is report 2 of 3 for (b)(4).This report is for 1 unknown matrixneuro screw.
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Manufacturer Narrative
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Device used for treatment, not diagnosis."scalp necrosis following peroperative embolization for meningeal tumors: two cautionary tales" (2013).Kirkman, m.A., sethi, h., & kitchen, n.D.Acta neurochir, 15, 1413-1415.This report is for an unknown matrixneuro screw/unknown quantity/unknown lot.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Search Alerts/Recalls
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