Additional narrative: this report is for an unknown tomofix plate/unknown lot.Part and lot number are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or 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 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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Device report from synthes (b)(6) reports an event as follows: it was reported that on an unknown date, the patient underwent an unknown procedure utilizing a tomofix plate.The patient had an adverse event of lateral hinge fracture following proximal biplane, when wedge was virtually closed.No post-operative complications reported.Patient outcome is unknown.No further information is available.This report is for an unknown tomofix plate.This is report 1 of 2 for (b)(4).
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