Additional procode: kwp;kwq;mnh;mni;osh.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).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 reports an event in (b)(6) as follows: it was reported that on an unknown date, the primary posterior lumbar interbody fusion (plif) at l4/5 was performed on the patient.On an unknown date, it was found that the patient had suffered from restenosis.On (b)(6) 2021 the patient underwent a plif revision procedure treating the restenosis.During the revision procedure, the surgeon found the loose screw which was replaced with a new one.No further information is available.Concomitant device reported: unknown rods (part# unknown, lot# unknown, quantity unknown ), unknown setscrews (part# unknown, lot# unknown, quantity unknown ), unknown cage (part# unknown, lot# unknown, quantity unknown ).This report is for one (1) 5.5 exp verse can scr 6.0x45.This is report 3 of 4 for (b)(4).
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