Due to the intra-operative events, the device was not successfully implanted.As such, implant/explant dates are not applicable.Complainant part is not expected to be returned for manufacturer review/investigation.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.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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It was reported that zip ties are not latching or engaging, during surgeries.Although the previous events were not reported, the sales consultant was told by one of the hospital¿s physician assistant's that the malfunction has been a reoccurring problem.The sales rep was not involved in any of the cases in which the events occurred therefore does not have any patient or procedure information.This was reported to the sales rep for the first time and he was told that this occurrence has happened at least 8 times.In every occasion the malfunctioned part was discarded.This is report 4 of 8 for complaint (b)(4).
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