It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.The following devices were also listed in this report: unitrax c-taper sleeve +0mm; cat#6942-7-065; lot#89095801, md.Universal cement restrictor; cat#b000-0240; lot#6m10236, osteonics univ.Distal spacer; cat#1067-0010; lot#wr2mh7, omnifit hfx hip stem size #06 132; cat#6070-0625a; lot#x1677d, simplex p full dose 1 pack; cat#6191-1-001; lot#rkc100, simplex p full dose 1 pack; cat#6191-1-001; lot#rlc110.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Device not returned to the manufacturer.
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