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.This report is for one of eight devices involved in this event, please refer to report 3013450937-2018-00036, 3013450937-2018-00037, 3013450937-2018-00038, 3013450937-2018-00039, 3013450937-2018-00040, 3013450937-2018-00042, and 3013450937-2018-00043 for the others.The device history records and sterilization batch release records were reviewed and indicated that the components involved met specification.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 complaint will be re-opened, and this report will be supplemented.
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Patient went into cardiac arrest, during a revision surgery, and was unable to be resuscitated.The revision surgery was performed to remove unknown components due to a comminuted supracondylar fracture on their distal femur and place an eleos distal femur limb salvage system.
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