This report is for an unk - screws: trauma/ unknown lot.Part and lot numbers are unknown; udi number is unknown.Investigation summary: 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.Without a lot number the device history records review could not be completed.Product was not returned.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 during the osteotomy surgery for maxillary and mandibular on (b)(6) 2019 via le fort i.It was confirmed some screws which inserted at maxillary were loose on (b)(6) 2019, the revision surgery was performed on the same day.Doctor comments: although 9 screws were loose, there was no problem with the product.Patient outcome was stable after revision surgery.Concomitant devices reported: unknown plate (part # unknown, lot # unknown, quantity 1), unknown screws (part # unknown, lot # unknown, quantity# 9).This is report 7 of 9 for (b)(4).
|