510k: this report is for unknown set screws/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 (b)(6) reports an event as follows: it was reported that on (b)(6) 2020, a l4-s1 posterior lumbar interbody fusion (plif) was extended to l3-s1 due to adjacent segment disease.Upon extension, it was discovered that the left s1 screw was broken.The shaft was left in situ and the head removed.A new left s1 screw was placed next to the old screw shaft.Procedure was successfully completed with a ten (10) minutes delay.There was no patient consequence.This report is for unknown set screws.This is report 3 of 3 for (b)(4) and captures the adjacent segment disease.The broken screw is captured under (b)(4).
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