This medical device report (mdr) was initiated as part of a retrospective assessment of complaints under onkos surgical capa (b)(4).As part of this assessment, onkos surgical re-evaluated all complaints received to ensure mdrs were filed when required.The results of this retrospective assessment prompted onkos surgical to file this report.The device history record and sterilization batch release record were reviewed and indicated that the component involved met specification.The operation notes were provided for review, which confirmed the adverse event.From the available information it was determined that the adverse event was not related to the manufacture of the implants or a non-conformance and this complaint has been closed.Should additional information be obtained the report will be supplemented.
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