This report is for an unknown biomaterial - cement/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k 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.
|
Device report from synthes reports an event in (b)(6) as follows: it was reported that an unknown procedure was performed on an unknown date.Effusion was found hypodermically.No further information is available on what device(s) was involved with, how the event took place, and so on.This report is for one (1) unknown biomaterial - cement.This is report 1 of 1 for complaint (b)(4).
|