(b)(4).Device is an instrument and is not implanted/explanted.Complainant part is not expected to be returned for manufacturer review/investigation, as it was reportedly discarded by the facility.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 during a bone grafting surgery while using the reamer, irrigator, aspirator (ria) device, the aspiration ports of the ria device became clogged with bone chips.The surgeon was able to clear the ports manually by running it in reverse.A delay of approximately ten (10) minutes was incurred and the surgery was successfully completely with no harm to the patient.The patient outcome was reported as no complications.This is report 1 of 1 for (b)(4).
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