Integra has performed a thorough review of the reported incident.The device was not returned for evaluation, as such the reported issue could not be confirmed or further evaluated.However, at the time of manufacturing, records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications.The investigation was unable to determine a root cause or establish a relationship between the device and the reported incident.No enhancements or improvements were generated for the reported condition.
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