Smith & nephew is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based upon information which smith & nephew, has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, smith & nephew, or its employees, that the report constitutes an admission that the device, smith & nephew, or its employees caused or contributed to the potential event described in this report.- attachment: [(b)(4) summary.Pdf].
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