The reported event, alleged of issue was confirmed based on information received from the sales representative.Based on investigation, the root cause was attributed to a user related issue.As noted by the sales representative, the failure was caused by a processing error by the facilities sterilization department.The prophecy guides were labeled with the incorrect patient information during central sterilization and mixed-up with guides for a different surgical procedure as a result.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this timea review of the labeling did not indicate any abnormalities.¿ the instructions for use were reviewed and states: "markings on guides and models provide case identifiers, such as case number, and must be legible.Before using the guides and models, check the identifier and confirm that it corresponds with the current case.Do not use the guide or the model if the case identifiers are not legible." ¿ no indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.
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