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.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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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Device report from synthes reports an event in (b)(6) as follows: it was reported that, the patient underwent the primary fusion procedure (l2/3).During a revision fusion (l2-4) with a screw in question was inserted at l3 left, which broke off at 10mm below the screwhead.The fragment was left in the lesion.Procedure was completed successfully without any surgical delay.This report is for one (1) 5.5 exp verse can scr 6.0x40.This is report 1 of 1 for (b)(4).
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