Reported by (b)(4), safety surveillance specialist, synthes: during an ad hoc safety assessment, we identified the following literature article reporting an extensive corrosive of the isola spinal system.Chromium ion release from stainless steel pediatric scoliosis instrumentation; thomas p cundy publication date: jan 2010.N=1 rod, ae revision and hematogenous infection.
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A complaint investigation will be performed.The complaint product is not available for the investigation.A supplemental report is not anticipated unless the results of the complaint investigation identify a corrective action or additional relevant information.Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the results.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Sample not available for investigation.
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