Both devices were implanted in (b)(6) 2010, the exact implantation date was not provided.Additional information and the return of the device have been requested.A review of the lot history records for this device did not reveal any non-conformances to specification or deviations in procedure.The risk management files were identified in the available reported information for this pe that require any changes to the current fmea, risk analysis, or labeling.This was a two-level implantation.This is 1 of 2 reports submitted on this event.
|