Additional information has been requested.A review of the build lot history records 8794 for cdl-637l s/n (b)(6) iwere exaqmined including the final inspection records and the in-process measurements.There were no relevant ncmrs associated with these lots.The devices met the m6-c product specifications including the axial stiffness and flexural resistance specirfications.Risk management files were reviewed and no new risks were identified.Based on the inspection of the retrieved m6-cs, in the absence of additional clinical data, radiographs, or radiographic analysis, the cause of this event was unclear.It is unknown if infection was suspected or confirmed.While some in vivo damage was noted on the cores, the majority of the damage appeared to be extraction damage.Due to the extent of the extraction damage and lack of additional clinical or radiographic information, it is unclear if the devices at c4/5 and c5/6 had failed mechanically at the time of removal.The device at c6/7 was grossly intact, indicating this device had likely not failed at the time of removal.The failure of this procedure and the removal of these devices was not clear.
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