The product was scrapped by the customer along with the other materials used during surgery.A lot number was not provided; therefore the sterilization and lot history records could not be reviewed.The internal, systematic microbiological monitoring of the product after manufacturing shows the endotoxin levels within specification.Based on the limited information available and the unavailability of the sample for testing, the cause of the complaint cannot be determined.The trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.No corrective action required.The investigation is complete.(report 2 of 3; see also 0001920664-2020-00173 & 0001920664-2020-00175).
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