Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, the patient underwent an anterior cervical discectomy and fusion (acdf) procedure using the skyline devices in question.(2) skyline drivers (part no.286830500) were unable to retain the unknown skyline screws.When attempts were made to attach the unknown screws to the skyline drivers, they disengaged.There was a surgical delay of (2) minutes.The procedure was successfully completed using bone wax to assist holding the screw to the driver until implanted.There was no patient consequence.This complaint is related to (b)(4).This report is for (1) unk - screws: skyline.This is report 4 of 8 for (b)(4).
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This report is for an unknown screws: skyline/unknown lot.Part and lot numbers 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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