Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).A device history record (dhr) review was conducted: manufacturing location: (b)(4).Expiration date: 28-sep-2016.Part number: 615.10.01s, cranios reinforced fast set putty 10 cc¿ sterile.Lot number: dsc4598 (sterile).Lot quantity: (b)(4).Sterility requirements on certificate were reviewed and determined to be conforming.This lot met all dimensional, visual, sterility and packaging criteria at the time of release with no issues documented during the inspection or release of the product that would contribute to this complaint condition.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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It was reported that on an unknown date, the patient underwent a removal of cranios reinforced fast set putty, one (1) titanium matrixneuro reconstruction mesh, one (1) 3 mm titanium matrix midface screw, one (1) 10 mm titanium matrix midface screw, and one (1) 4 mm titanium matrix midface screw due to c difficile infection postoperatively.Original date of surgery was on (b)(6) 2015.The patient was on a cephalexin antibiotic therapy due to complication known on (b)(6) 2015.It is unknown if there was surgical delay.Procedure and patient outcome was unknown.This report is for one (1) cranios reinforced fast set putty 10 cc-sterile.This is report 1 of 5 for complaint (b)(4).
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