This report is for an unknown mono/polyaxial screws: click'x /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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Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date, a patient experienced a possible post-op allergic reaction to a click x system and oracle peek cages.Non-sterile implants were implanted in 2011 and remain in the patient.Concomitant devices reported: locking/set screws: click (part number unknown, lot unknown, quantity 1), cage/spacers: oracle (part number unknown, lot unknown, quantity 1), rods: click x (part number unknown, lot unknown, quantity 1).This report involves one (1) unknown mono/polyaxial screws: click x.This is report 3 of 4 for (b)(4).
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