Additional product codes: hrs, jds.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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It was reported that on april 23rd, 2019, the package was received empty.The only thing inside was the packing slip which shows the implants were shipped.There was no patient involvement.Additional products for this event are captured on related complaint (b)(4).This report is for a cortex screw.This is report 7 of 7 for (b)(4).
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