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: part number: 615.10.01s, cranio's reinforced fast set putty 10cc ¿ sterile.Lot number: dsd8462 (sterile).Manufacturing location: (b)(4) / inspected and released by: (b)(4).Release to warehouse date: 30-dec-2016.Expiration date: 28-jul-2018.Lot quantity: 126.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 28-dec-2016 was reviewed and determined to be conforming.Sterility parameters documented on certificate were reviewed and gama is specified at 25 min.- 32 max.The max results are documented at 31.9 and 32.2.It is unknown whether exceeding specified maximum may have contributed to the reported complaint condition.This lot met all visual 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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