(b)(4).This report is for an unk - synflate/vbs/unknown lot.Part and lot numbers are unknown; udi number is unknown.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 as no product was received.The investigation could not be completed, no conclusion could be drawn at the time of filing this report.The product was not returned.Based on the information available, it has been determined that no corrective and 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 on (b)(6) 2021, the patient underwent for a percutaneous vertebroplasty surgery for treating spinal canal stenosis.During the surgery, the surgeon inflated the stent balloon but only one end of the balloon was inflated normally.The cement needle was not able to be inserted.The surgery was completed with 30-minutes delay.No further information is available.This complaint involves two (2) devices.This report is for (1) unk - synflate/vbs.This report is 1 of 2 for (b)(4).
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