Device report from synthes reports an event in korea, south as follows: it was reported that on (b)(6) 2023, the psi was removed due to an infection in the patient's operated area(patient had a previous history of infection).No patient consequences.This report is for one (1) psi sd800.435 peek implant.This is report 1 of 1 for complaint (b)(4).
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Additional narrative: complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j sales representative.Investigation summary: product was not returned.Based on the information available, it has been determined that no corrective and 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 history lot: product code: sd800.435, lot number: 4837p34, manufacturing site: mezzovico, release to warehouse date: 27 feb 2023, a manufacturing record evaluation was performed for the not-sterile finished lot number, and no non-conformances were identified.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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