Complainant part is not expected to be returned for manufacturer review/investigation.Investigation summary: 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 history: manufacturing location: (b)(4) / inspected and released by: (b)(4).Release to warehouse date: 15-jul-2015.Expiration date: 28-oct-2016.Part number: 615.03.01s, cranios reinforced fast set putty 3cc ¿ sterile.Lot number: dsc7714 (sterile).Lot quantity: (b)(4).Purchased finished goods traveler met all inspection acceptance criteria.Inspection sheet, incoming final inspection, met all inspection acceptance criteria.Certificate of conformance supplied by (b)(4) dated 26-jun-2015 was reviewed and determined to be conforming.Sterility parameters documented on certificate were reviewed and determined to be conforming.This lot met all 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.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 an acoustic neuroma resection retrosigmoid procedure.Patient was implanted with an unknown bone plates and putty cement.Postoperatively, the patient's surgery was complicated by swelling of the neck which required the patient to be kept intubated for an extra two days for airway protection.The patient's shoulder was mildly weak after the surgery and was attributed to brachial plexus stretch injury.The patient is making good progress and the post operative complications were resolved.Patient's outcome is unknown.This is report 1 of 3 for (b)(4).
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