Device report from synthes reports an event in japan as follows: it was reported that the patient underwent an intervertebral degenerative fusion (l4 to l5) surgery with expedium and t-pal on (b)(6) 2022.After the surgery, the patient was found to be infected around the cage.Therefore, a revision surgery was performed on (b)(6) 2022.Cleansing and debridement were performed.This report is related to (b)(4), which reports that the patient bled 2000ml during the revision surgery and passed away after the revision surgery.The following complaints are related: (b)(4) (spd) ¿ unknown screw ¿ reflects infection with debridement.(b)(4)(spn) ¿ unknown cage - reflects infection with debridement.(b)(4)(spd) ¿ unknown screw ¿ reflects the bleeding and death.(b)(4) (spn) ¿ unknown cage ¿ reflects the bleeding and death.This report involves one unk screws.This is report 1 of 1 for (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.This report is for an unknown screws/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter occupation: reporter is a j&j employee.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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