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.H10 additional narrative: d9: complainant part is not expected to be returned for manufacturer review/investigation.E3: reporter is a j&j sales representative.G4: device is not distributed in the united states, but is similar to device marketed in the usa.H3, h4, h6: 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 japan as follows: it was reported that this was an unknown surgery performed on (b)(6) 2024.On (b)(6) 2024, the sales rep was informed that the cement leakage into blood vessels had happened in that surgery.In the surgery, the fenestrated screw was installed, and there was no problem with the location.After mixing the cement in question, injection began.The injection was stopped due to possible intravascular leakage.Postoperative ct showed vascular leakage and cement leakage from the same vertebral body into the spinal canal.Since the leakage was only a trace amount, there has been no impact on patient so far, and the patient is currently under observation.There was no surgical delay.No further information is available.Remarks: (b)(4) are involved with the same event.(b)(4) (synthes spine): cement (b)(4) (depuy spine): screw this report is for one (1) vertecem v+ cement kit this is report 1 of 1 for complaint (b)(4).
|