Event occurred on an unknown date in 2019, exact date is unknown.This report is for an unknown plate/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.(b)(4).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 the patient underwent facial enlargement surgery of the anglomandibular part utilizing a patient-specific implant - polyetheretherketone (peek) on (b)(6) 2019.After the surgical operation, the patient presented swelling on the left side of the face affected by the prosthesis.The patient is on antibiotic therapy.It was unknown if there was a surgical delay.Patient is now healthy, and swelling is gone.Patient is well now.This report is for one (1) unknown plate.This is report 3 of 3 for complaint (b)(4).
|