(b)(4).Due to the intra-operative events, the device was not successfully implanted.As such, implant/explant dates are not applicable.The subject device fragment is not expected to be returned to the synthes manufacturer for evaluation.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|