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 employee.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.
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Device report from synthes reports an event in japan as follows: it was reported that this was a percutaneous vertebroplasty (l3) for l3 fracture on oct.18, 2023.In the surgery, the cement was prepared as per the procedure manual.It always reached the proper viscosity in 10 to 12 minutes, but hardening was observed after about 5 minutes.A spare cement was used.The surgery was completed successfully with 30 minutes surgical delay.Patient status/ outcome: stable no further information is available.This report is for one (1) vertecem v+ cement kit.This is report 1 of 1 for complaint(b)(4).
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