This initial report is being filed after the due date as the initial submission was found to have not been received during an attempt to submit the follow-up report.At that time, the error message "error: initial report / prior supplement has not been received.The initial report is missing." alerted orthalign, inc.Of the issue prompting the submission of this initial report.An investigation of the navigation unit and it's event log was performed.The event log was corrupted signifying an electronics issue with the navigation unit.A review of the device history record (dhr) was conducted.The device passed all manufacturing specifications prior to release.Orthalign, inc.Will continue to monitor this issue and take action when/if alert limits are exceeded.
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