Device remained implanted; as such explant date is not applicable.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is patient.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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It was reported that on an unknown date, the patient had an allergic reaction to devices implanted after an unknown surgery.Patient had itchiness, next patient turned red and had numbness from his neck to his left shoulder.The patient was implanted with a titanium vectra plate and four (4) titanium self-drilling screws on (b)(6) 2015 for an unknown procedure.The patient stated that he's allergic to nickel and wants to know if the implants contained the mineral.The symptoms of rash occurred almost immediately after surgery.No other information was provided.This report is for one (1) 4.0mm ti cervicle self-retain screw.This is report 4 of 5 for complaint (b)(4).
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